HC-opp

 
 
   
  A partial listing of HCI's current healthcare opportunities are listed below. If you are seeking a certain position in a specific area, and do not see it, please contact us.
   
 
   
   
 
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Vice President Human Resources

 

Our client, a well know manufacturer of sophisticated electronic products, seeks a Vice President Human Resources to run all HR functions with a special emphasis on compensation, training and recruiting as the company in growing rapidly. These products go into the healthcare, education, hospitality and commercial/industrial market places.

 

 

SCOPE OF RESPONSIBILITIES

Following are some abridged points.  Position details follow these abridged points:

  • Staffing the company with superior talent is the highest priority.
  • Filling key open positions timely is critical.
  • Maintaining strategies for employee retention.
  • Maintaining an efficient learning center hub and spoke concept to track and maintain all of the training modalities necessary to meet all of the training needs and requirements across the company.  This would include employee self-improvement modules.
  • Maintain high quality communication practices with company employees.

HR responsibilities include:

  •  Develop staffing strategies and implementation action plans and programs to identify talent within and outside the corporation for filling key positions. Identify appropriate and effective external sources for candidates for all levels within the company.
  • Develops progressive and proactive compensation and benefits programs to provide motivation, incentives and rewards for effective performance and to provide programs which utilize an employee and company partnership for the short and long-range health and welfare protection of the employees.
  • Develops programs to allow the corporation to embrace applicants and employees of all backgrounds and to permit the full development and performance of all employees.
  • Develops human resource planning models to identify competency, knowledge and talent gaps and develop specific programs for the filling of the gaps. Areas of activity will include talent management through proper succession planning programs for key contributor and management positions, training and development programs for preparing employees for more significant responsibilities and general business development programs to enhance employee knowledge and understanding of the business of the company and the software industry.
  • Continually assess the competitiveness of all programs and practices against the relevant comparable companies, industries and markets.
  • Establish credibility throughout the organization with management and the employees in order to be an effective listener and problem solver of people issues.
  • Develops appropriate policies and programs for effective management of the people resources of the corporation. Included in this area but not limited only to the following would be programs for employee relations, affirmative action, sexual harassment, employee complaints, external education and career development.
  • Enhances and/or develop implements and enforces human resources policies and procedures of the organization that will improve the overall operation and effectiveness of the corporation. In particular, manage the human resource information systems database and necessary reports for critical analyses of the HR function and the people resources of the corporation.

 

 

Specific HR Tasks:

  •  Manage the entire recruiting process, from position definition and requirement through offer and assimilation into the organization.
  • Refine the existing process to drive down recruiting costs, improve cycle time, and increase the quality of candidate being interviewed.
  • Develop an annual recruiting strategy and implementation plan. Implement the plan as agreed upon with Senior Management. Must be able to adjust recruiting practices to meet demands associated with company growth.
  • Employ proactive recruitment methods to source qualified passive candidates for exempt positions, many of which require highly specialized technical skills and experience.
  • As needed, work with other parts of the organization to improve their effectiveness in interviewing, selecting and assessing candidates, and to act as a champion for RF Technologies. Also, work with them to understand how to use their own networks to facilitate recruiting.
  • Continue effective relationships with colleges for college recruiting and build necessary college relationships to fill gaps in entry level recruiting.
  • Continually enhance the use of tools and resources for effective recruiting, including the Internet, in-house applications, associations, etc., and employ proactive to ensure that well-qualified candidates are sourced to meet the talent needs of the organization.
  • Carry out supervisory responsibilities including interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Develop and maintain compensation programs/plans for the entire Company.
  • Develop and maintain human resources policies and procedures that comply with State and Federal laws and are consistent with company philosophy.
  • Oversee Surveys and Mandatory Reports (EEOC, VETS 100, etc.)
  • Plan, organize, and control all activities of the human resources department involving: employee services, new employee orientation and on-boarding processes, and maintenance of employee records.
  • Recommends employee relations practices necessary to establish a positive employee-employer relationship and promotes a high level of morale.
  • Maintain personnel files, including employee performance issues and PIP plan documentation.
  • Participate in developing department goals, objectives and systems and recommend changes as appropriate.
  • Ensure company is prepared for all dealings with labor counsel and government agencies including the preparation of all requested or required reporting information.
  • Establish and coordinate in-house training programs that address company needs.
  • Oversees the content of the Employee Handbook
  • Must be able to manage the corporate training hub, working with all functions within the company for developing and delivering the most effective training for internal and external needs.

 

EXPERIENCE AND REQUIREMENTS

 

  • To perform this job successfully, an individual must be able to understand and relate to each essential duty.  The requirements listed below are representative of the knowledge, skill and/or ability required.      
  • Manufacturing HR experience with a thorough understanding of large and small company best practices, and prior experience relating with peers at the VP of HR level.
  • Over 10 years progressive experience; in a position within a manufacturing organization with a large national customer base gaining knowledge in areas:
    • Broad companywide HR experience
    • Hands on recruiting experience and understanding current recruiting methodologies.

  

 

QUALIFICATIONS

  • Requires a minimum of a bachelor’s degree and a technical degree would be a plus.
  • Eight to ten years’ experience in human resources in a mid-size manufacturing environment preferred.
  • Excellent business communication skills are necessary
  • The ability to problem solve a variety of situations simultaneously is required
  • Must be able to execute reasoning skills and work well independently
  • Strong detail orientation, analytical skills, and computer skills are necessary
  • Ability to handle multiple projects and to complete them in a timely manner is essential
  • Must be a natural at multitasking
  • Must have proven ability to plan and organize effectively
  • Must have demonstrated oneself to be trustworthy and capable of maintaining a strict adherence to confidentiality
  • Various Certifications is a plus
   
   
 
 
 

Plant Manager

 

Our client a leading manufacturer of Vitamins and Pharmaceutical products seeks a Plant Manager/Director of Manufacturing for a new Pharma plant that they are building in the Los Angeles area. 

 

The Plant Manager/Director of Manufacturing is responsible for a safe work environment, cGMP compliance, efficiency, hiring qualified staff, meeting established goals/objectives and setting high quality standards set forth.

 

Essential Duties and Responsibilities

  •  Maintain a safe work environment within the company by adhering to company policies and procedures.
  •  Ensure and enforce the high quality standards that are set for the company.
  • Transition Company from dietary supplements to manufacturing drug products.
  • Maintain facility in a state of cGMP compliance.
  • Ensure staffing requirement  are meet per company expectations
  • Maintain discipline among the staff
  • Must engage, coach and motivate all employees in support of company goals.
  • Look to manage all departments so as to improve department efficiencies and improve employee productivity.
  • As the plant manager you are responsible for the completion and accuracy of all designated company forms that will be completed by employees within their departments.
  • Email's regarding business needs should be read and responded to throughout the day in order to maintain business productivity.
  • Must forecast and accurately account the amount of materials needed on a daily basis.
  • Maintain excellent communication between the managers’ and direct reports.
  • Ensure that your approach to business decisions is dictated by the needs of the business.  Consult with the Director of Operations when needing to understand what the current business priority may be.
   
   
 
 
 

Manager Product Sales/Channel Partner

 

Our client, a well-known Milwaukee based manufacturer of Medical Electronic products, seeks a Manager Product Sales/Channel Partner.

 

SCOPE AND RESPONSIBILITIES

Will be responsible for defining and communicating the strategic sales plan and developing the plans for current and future products as well as being engaged in the day to day decisions regarding sales, product development, product marketing, product releases and product retirement. Will work cross functionally with Sales and Marketing, Accounting, Production and Operations and other functional areas in ensuring timely and seamless introduction of products to the market place. 

 

Specific responsibilities include:

  • Engage customers, analyze and assess markets, and research technologies to derive insights regarding potential solutions to meet customer needs.
  • Lead the identification, research and selection of new product enhancement and development opportunities, including proposals to activate new research and development projects.
  • Ensure product enhancements and new product development process is aligned with customer and industry needs. “Voice of Customer” feedback is essential.   
  • Collaborate with various departments and 3rd parties to ensure product delivery and quality goals are achieved.
  • Work with marketing and sales to develop and implement marketing and sales plans for new product introductions.
  • Develop and maintain a 3-4 year solutions roadmap for the product lines.
  • Managing products through the new product development cycle while working with technical service and support, marketing, finance and sales to achieve revenue and profit goals.
  • Provide technical sales support on significant opportunities as deemed necessary.
  • Identify product enhancements that balance a favorable return on investment with customer needs.
  • Keeping current on our competitors and communicating internally competitive comparisons.
  • Collaborate with various departments to ensure product delivery and quality goals are achieved.
  • Coordinate internal training efforts for sales, technical support and any other impacted areas on any new products.
  • Work with marketing and sales to assist in the development and implementation of marketing and sales plans.
  • Developing product specifications to fulfill product functional requirements.
  • Developing third party purchasing specifications for OEM products.
  • Working in collaboration with third party product manufacturers and design firms.
  • Rapid prototyping and proof of concept.
  • Product test and validation
  • Interfacing with upstream marketing, and customers
  • Managing third party manufacturing
  • Project management
  • Quality assurance
  • Needs to handle both direct selling as well as channel sales
  • Needs to continually be improving the channel sales partners

 QUALIFICATIONS

  • Bachelor’s degree in engineering is preferred, MBA a strong plus.
  • Exceptional project management skills are required with the proven ability to manage timelines and hold people accountable, especially 3rd party partners.
  • Experience in pricing is desired
  • Proven experience managing multiple projects at any given time
  • Demonstrates the ability to think outside the box
  • Must be comfortable using MS Office Suite products, in particular MS Excel, MS PowerPoint, and MS Word
  • Ability to create projections based on statistical analysis
  • Experience with budgeting models and project planning
  • Must have experience authoring detailed product requirements specifications
  • 10+ years of experience in developing and launching complete products
  • Medical device manufacturing and development experience
  • Experience with patient safety products
  • Delivering products to the Long Term Care, Hospital and Home Care markets
  • Experience with regulatory requirements of UL, ETL, FCC and FDA
  • Experience with product packaging and basic mechanical design
  • Experience working with offshore manufacturers and suppliers
  • Ability to document design
  • Test procedure development

 

PERSONAL ATTRIBUTES                       

  • Ability to multitask and move projects forward with speed and accuracy
  • Project management
  • Effective oral and written communication
  • Self-motivation
  • Work independently
  • Work in a team environment

 

CULTURAL & ORGANIZATIONAL EXPERIENCES

The successful candidate must have proven experience working in an environment that is informal yet requires an appropriate level of discipline and process.  Working in an environment that is lean and rewards initiative and responsiveness is critical.  Having the confidence to make decisions and move forward without continual feedback or reassurance is important.  Experience in an environment that is demanding in terms of volume of work and results is necessary.  The candidate must bring a passion for the customer and understand how to build a customer driven team, doing so through his/her own example of behavior.  Finally, being able to constructively challenge other leaders in the organization using fact-based rationale is important.  Integrity, respect, persistence and openness are core to this organization.  

   
   
 
 
 

Regulatory Affairs Specialist

 

As you may be aware, I have been placing people in the Biotech/Pharmaceutical/Healthcare industry on an exclusive basis with large and small companies, nationally, for over twenty years.

 

Our client a leading Milwaukee based medical products company seeks a Regulatory Affairs Specialist.


The company is a global, multi-platform healthcare solutions manufacturing company. Invested in a broad and ever-growing line of medical technologies, this company manufactures and markets products and solutions for diagnostic and therapeutic procedures, continuing care and rehabilitation, and medical device OEMs. Company owns and operates manufacturing facilities in Wisconsin, Colorado, Virginia, and Saigon, Vietnam. Our Technical Research and Training Center in Denver, CO boasts a best-in-class clinical education and product training center for healthcare providers worldwide. 

This position will coordinate and document internal and external regulatory processes to support worldwide compliance requirements.  The position may compile and prepare materials for submission to regulatory agencies.

Responsibilities Include:

  • Prepare global regulatory files/submissions for product registration as assigned.
  • Develop and maintain EU technical files and/or design dossiers to new EU MDR standards.
  • Provide regulatory support for on-going globally product registrations as assigned.
  • Review and approve proposed design changes and ECOs to assess regulatory impact.
  • Participate on project and product development teams to provide early guidance, design control reviews, and Regulatory Strategy.
  • Review and approve labeling for domestic and international compliance including meeting US and EU UDI requirements.
  • Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
  • Coordinate Certificates to Foreign Governments, Free Sales Certificates, Apostilles, and notarization.
  • Maintain regulatory data, GUDID, and FDA medical device listings.
  • Perform other related duties and special projects as required by management.

 

 

Position Qualifications:

  • Bachelor of Science Degree in technical, engineering, and/or scientific discipline.  Professional designations are not required but training and certificates in regulatory affairs are a plus.
  • Minimum 2-3 years in a regulated industry with applied experience/knowledge in regulatory (preferred), quality or similar position.
  • Ability to execute assignments independently as assigned. Must possess strong organizational skills. Must possess strong written and verbal communication skills. Must possess demonstrated ability to handle multiple priorities simultaneously. Proficient in Microsoft Office Products.
  • Knowledge of 21 CFR 820, EU MDD/MDR, ISO 13485, and ISO 14971 (desired)

Benefits

  • Competitive compensation
  • Full medical and dental insurance
  • Modern office space and environment
  • Paid vacation 
  • 401k with employer match

 

Primary on product development for pharmaceutical softgels (OTC and Rx)

  • Will work with, oversee, and manage/coordinate Product Development formulator for the above
  • Will work with, oversee, and manage/coordinate respective Product validation efforts and documentation, including respective QC testing and stability

Background Preference:

  • Pharmaceuticals experience in developing, validating, documenting, and filing OTC/Rx products; preferably softgel
  • 5-10 years of direct involvement and experience above.

 

   
   
 
 
 

Corporate Strategic Account Director

 

Our client, one of the Top 20 Medical Device companies in the world seeks a Corporate Strategic Account Director to handle IDN Sales in Philadelphia and the surrounding area.

 

Position Summary:

 

The Corporate Strategic Account Director position combines multiple functional attributes such as sales, business development, and marketing.  The successful Strategic Account Director drives sales growth, develops account strategies, manages executive relationships, and improves overall customer satisfaction at their assigned corporate accounts.  Increase sales of the overall company portfolio within Targeted Strategic Accounts utilizing designated distributors and programs established by National Accounts.  Acting as the single point of contact, develop and maintain relationships with national and key regional distributor sales leaders and top distributor reps within area. 

 

Responsibilities / Essential Duties: 

  • Development and execution of the IDN strategy for IDNs & Strategic corporate accounts consistent with the company’s business strategy. 
  • Generates sales of existing and new products and solutions portfolio at their strategic corporate accounts. 
  • Uses a high level of financial and business acumen to assess and cultivate new business and leveraged business opportunities. 
  • Gains input and trend information form major customer groups through direct contact with such groups, organizations and other vendors.
  • Cultivates, promotes and maintains VIP relationships.  Maintains a productive and beneficial relationship with influential executives.
  • Targets top/middle of customer continuum and calls on the “C” suite to build and maintain a relationship with the financially responsible party and key decisions makers at the account.
  • Demonstrates a deep understanding of the account, including Executive support to deliver solutions based value proposition.
  • Provides leadership in the planning, designing, and implementing of strategic business objectives at strategic corporate accounts. 
  • Defines vision, strategies and tactics required for profitable and sustained growth at strategic corporate accounts.
  • Provides competitive intelligence, input and trend information to management and marketing.
  • Accountable for price and contract negotiation.
  • Provides product input and feedback to marketing on behalf of the account.

Ideal candidate will have minimum of 5-10 years sales, sales management, national accounts, IDN experience within the Medical Device field. 

  • Manages account planning across products/solutions and account administration.
  • Conducts quarterly business reviews with the account.
  • Develop and maintain relationships with key distributor sales directors.
  • Attend and manage key distributor regional and national sales meetings.
  • Drive consistent interaction field interaction with top distributor representatives and key distributor regional management teams.

Desired Qualifications / Experience:

  • Relevant experience in prospecting new business development at IDN key corporate accounts, both GPO and Distribution.
  • Ability to lead multi discipline sales team through a defined selling process; multi-level, high value, complex accounts. 
  • Experience in consultative sales, with the ability to develop technical value propositions.
  • Ability to develop relationships from C-Suite to factory floor.
  • Experience in developing profitable sales opportunities, product knowledge (width not depth), identify develop and secure opportunities to deliver annual revenue plan, and negotiate annual pricing contracts. 

Compensation will include an excellent base, bonus program along with company car and all expenses. 

   
   
 
   
 
 

Senior Regulatroy Affairs Specialist

 

Our client a well-known Madison based Medical Device company is currently seeking a Senior Regulatory Affairs Specialist.  This position is based in our Middleton, Wisconsin location. Founded in 1989, this company is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Their products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions. 

   

The Senior Regulatory Affairs Specialist works in preparation and coordination of submissions in compliance with relevant regulations. This includes both domestic and international submission types. Examples include, but are not limited to: 510K submissions, Technical Files, obtaining documents for export such as Certificates to Foreign Governments and Certificates of Free Sale, answering distributor requests on a timely basis for regulatory and technical data in support of medical device registrations and following Domestics and International Product Standards/Practices.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

  • Facilitate, prepare, and submit Premarket Notifications  - 510(k)s.
  • Prepare and submit Design Dossier and Technical Files.
  • Review critical documents to assure completeness, and prepare responses to in-country representative or regulatory agency. 
  • Prepare regulatory assessments for new products and changes to existing products to determine the appropriate regulatory pathway to market.
  • Review documentation required to support various regulatory activities.
  • Represents regulatory affairs on project teams.
  • Review and keep current with FDA regulatory requirements and trade publications.

QUALIFICATION REQUIREMENTS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education and/or Experience  

  • Bachelor's degree (B.A.) from four-year college or university in a Technical related field.
  • 3 – 5 years experience in Medical Device Field, Regulatory and/or Quality area.
  • Must have experience and proven records of 510K submissions and working knowledge of FDA and international regulations.

Other Skills and Abilities

  • Proficiency in MS Word, MS Outlook, Excel, PowerPoint and Portable Document Format (PDF) required.
  • Experience registering medical devices outside of the United States is preferred.
   
   
 
 
 

Manager of Quality Control

 

Our client is currently seeking a Manager of Quality Control for a leading manufacturer of Pharmaceutical products between the San Diego and Los Angeles area. 

 

Summary:   Quality Control Manager is responsible for the whole oversight of the Quality Control department.  They are to appropriate, delegate, and review Quality Control operations and related tasks to ensure company's full Quality Control support as well as provide technical and operational guidance and training to subordinate staff and other departments within the organization. They will need to strategically ensure the successful performance of the Quality Control group in properly evaluating and testing raw materials, in-process materials, finished products, and any other testing needs, as well as ensuring technical review, cGMP compliance as relating to laboratory operations, and customer technical support.  The individual will need to review the systems and the output of the Quality Control group for compliance to company policies and the quality requirements required in the dietary supplement industry.

 

Essential Duties and Responsibilities include the following.   Other duties may be assigned.

  • Thoroughly reviews and verifies Quality Control systems and operations within the department as well as in support of the organization.
  • Oversees and technically reviews company’s sanitation program and systems.
  • Represents company’s Quality Control operations as needed in customer and regulatory audits, meetings, qualifications, and/or any other such required instances.
  • Oversees that all proper SOPs, test methods, documentation, training, qualification and programs, investigations, compliance, and system optimization as relating to the Quality Control group are in place and are appropriately maintained.
  • Verifies systems are in place, effective, and adhered by the Quality Control department as relating to raw materials, in-process materials, finished products, test requests, and any other testing, qualification, and technical needs for successful quality control support of company’s operation.
  • Oversees that proper testing and methodologies are executed respective of company’s quality systems.
  • As necessary, thoroughly reviews completed and/or prepared Quality Control documentation and dispositions or endorses appropriately upon verification of documentation as accurate, true, and complete.
  • Oversees that proper testing of raw materials and finished products are being carried out and completed in a timely manner, adhering to all set schedules, confirmed by Quality Control staff and committed by self, and/or based on reasonable demand of company’s operational support.
  • Authors and/or reviews Quality Control related SOPS, while ensuring proper adherence to by subordinate Quality Control staff.
  • Develops, transfers, authors, oversees and/or reviews Quality Control Test Methods, while ensuring proper execution of approved methods by Quality Control staff.
  • Maintains a strong conceptual understanding of the processes, procedures, and scientific concepts practiced in the Quality Control Laboratory.   Provides Quality Control staff with respective guidance and support.
  • Must exemplify adherence to all safety, cGMP, and company’s operating procedures, particularly those of the 6 series, while keeping accountability of other QC staff to the same.
  • Quality Control Manager must have the ability to be flexible, handle and support multiple projects simultaneously and adjust personal style to adapt to increased business pressures and work well under pressure while performing all tasks in an accurate, complete, and appropriate manner.
  • Quality Control Manager must have the ability to communicate effectively inter- and intra- departmentally   matters as pertaining to Quality Control.

Education/Experience:

Minimum Bachelor's Degree;  Master's degree  (M.A.) or equivalent preferred; with a minimum of seven  years  related  experience and/or training,  of which  a year to two of managerial experience a plus;  or equivalent combination of education, experience, background, and assessed aptitude and capacity.  Degree in the sciences as relating to Microbiology and/or Chemistry preferred.

   
   
 
   
 
 

Regulatory Manager

 

Our client is currently seeking a Regulatory Manager to manage all regulatory programs to support product development and ensure compliance with all global regulatory programs that apply to company’s products. This is a hands on position that will manage the generation of all medical device registrations. 

  • This person must be a degreed professional with 5+ years of Medical Device Regulatory Affairs experience.
  • Have experience authoring and medical device registration with the US FDA, European Union and Health Canada.
  • Have authored 510(k)’s.
  • Domestic and International experience required.
  • Manager post-market surveillance.
  • Identify any clinical data requirements for global product licensing.
  • Create regulatory compliance plans to meet requirements for country submission.
  • Knowledge of global medical device regulations and standards such as ISO 13485, ISO 14971, CMDCAS, 21CFR 820. 

Company is offering a base and bonus with excellent benefits.

   
   
 
   
 
 

Director of Quality and Regulatory Affairs

 

Our client, a leading contract packager of pharmaceutical products, seeks a Director of Quality and Regulatory Affairs.

 

Job Summary: Responsible for the development, alignment and implementation of the Company’s Quality Management Systems, Regulatory and Complaint Management strategies.  Provide insights, solutions and direction on general business matters.  Direct and lead the company’s policies involving government compliance as well as national regulations.

 

Essential Functions:

  • Oversees the establishment, implementation, and maintenance of the quality and regulatory management systems
  • Serve as the Designated Representative to government officials of states and other entities
  • Designs, develops and maintains quality systems
  • Responsible for Complaint Handling, Compliance, and FDA issues
  • Ensures that cGMP requirements and quality standards are recognized, understood and maintained across the Company
  • Prepares and leads the audit processes for the internal quality system, customer, DEA and FDA
  • Identifies corrective actions and drive associates to accomplish correction action efforts
  • Monitors changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
  • Makes recommendations for corrective and preventive actions necessary to ensure conformity with regulatory rules and guidelines
  • Ability and willingness to use accurate judgment, and make timely decisions
  • Ability to identify and resolve problems in a timely manner and gather and analyze information skillfully
  • Observe and apply organizational policies, laws, rules and regulations
  • Comply with safety regulations and maintain clean and orderly work areas
  • Participate in and complete all company-required training
  • Work requires a flexible schedule, occasional weekend and / or evening work

 

Qualifications:

  • Bachelor’s Degree required in Technical or Medical field, or a closely related field Master’s Degree a plus
  • 5 to 10 years of experience in Quality Management
  • Strong Knowledge of cGMP Requirements
  • Knowledge of current regulatory requirements and industry standards particularly in the areas of manufacturing and packaging, label control, document management and investigations
  • Knowledge or experience in Complaint Handling
  • Strong knowledge and experience in a highly regulated or FDA environment
  • Strong supervisory and leadership skills
  • Proficiency with Microsoft Office programs such as Word, Excel and PowerPoint
  • Well-organized and detailed oriented professional with strong verbal and written communication skills
   
   
 
 
 

Director of RA/QA

 

Our client, a well-known Chicago area Medical Device company seeks a Director of RA/QA.

RESPONSIBILITIES

Organizational Leadership

  • Lead the Quality and Regulatory organizations by example, promote and sustain the Company’s vison, mission, values and culture, and ensure employees are treated with respect and encouraged to meet their full potential.
  • Build a team that is qualified, collaborative, hands-on, and focused on results in order to execute the Quality and Regulatory strategy.
  • Actively guide the recruitment, training, development and retention of the personnel to ensure the necessary capabilities and skills.
  • Create a team that has an advanced understanding the standards, regulations, and tools to support the company in meeting all Quality and Regulatory requirements
  • Provide direction, defining development opportunities, setting expectations, measuring performance, motivation and coaching, to direct reports.

Administration and Standards

  • Develop, present for approval, and ensure effective execution of the annual Quality and Regulatory Affairs plan. These plans must be based on an understanding of global standards and anticipation of changes in the future.
  • Define actionable metrics to measure Quality and Regulatory performance, monitor periodically and frequently to identify gaps and to execute improvement opportunities.
  • Manage and ensure compliance with all procedures and policies concerning quality, medical device regulations (ISO 13485, 21CFR820.30, 93/42/EEC, and CMDCAS]), safety, and human resources.

Quality and Regulatory

  • Monitor, implement, manage, and improve overall Quality and Regulatory functions, including the Quality Management System, document control, risk mitigation, raw material qualification, Quality Control testing, CAPA & Deviation reports, customer complaints, internal audits, and regulatory filings.
  • Initiate and design of change documentation, Device History File (DHR), and Device History Records (DHR/Batch Records), Device Master Record (DMR).
  • Facilitate timely review of critical documentation and reviewing document drafts for format, clarity, grammar and spelling.
  • Respond to and report incidents to all approved markets.

 

Supplementary

 

  • Perform other work related duties and special projects as required.
  • Participate in ongoing training to maintain and update skill sets as appropriate.
  • Establishes and/or maintains a safe work environment according to federal, state, and company policies and OSHA if applicable

GENERAL PERFORMANCE AREAS:

  • Communication: Speak effectively in individual or group situations. Listen actively. Follow safe communication protocol. Take responsibility for facilitating information exchange among subordinates, peers, and managers. Maintain open and honest communication in the sharing of ideas and events.
  • Innovation: Apply new and unusual ideas to tasks and projects. Research ways to improve current status or to develop new products.
  • Knowledge: Demonstrate the understanding and practical skills required by the job responsibilities and objectives.
  • Initiative: Recognize and seize opportunities outside of normal job duties. Implement new projects. Do more than is required by taking on extra tasks to meet organizational goals.
  • Teamwork: Maintain effective relationships with others. Support and participate in groups. Solicit input of others and builds on feedback. Participate actively in team decision making.
  • Customer Focus: Display a positive and professional image to internal and external customers. Address all issues as they arise or refer to the appropriate area of expertise as required.
  • Organization: Effectively organize tasks. Meet deadlines. Separate non-essentials from critical data. Accomplish expected volume and quality of work. Perform work accurately and neatly.
  • Results-Oriented: Identify problems, seek and consider alternative solutions while ensuring quality is maintained.
  • Leadership: Motivate and guide others through skill, understanding, knowledge and trust. Create ownership. Set performance standards by example.

QUALIFICATIONS, SKILLS and WORKING CONDITIONS

Education
BS/BA degree, Master's degree preferred, in a scientific or engineering discipline.

Experience
10 years previous experience in the medical device industry Quality and/or Regulatory role.

5 years previous experience in a leadership capacity in the Quality and Regulatory function with a proven track record in developing and maintaining excellence in the Quality Management System.

   
   
 
   
 
 

Director of Engineering

 

Our client, a leading Medical Products company based in Northern Illinois / Southern Wisconsin is seeking a Director of Engineering.

 

The Director of Engineering will oversee and enhance an engineering organization in the development of leading edge medical products.  Key priorities of this engineering organization include satisfying end user needs; improving talent management; establishing functional excellence; and the realization of cost effective product development activity.  This role requires extensive hands-on experience in the development of complex multidisciplinary medical devices.  The Director has responsibility for ensuring a high level of technical competence and job performance standards, developing and administering budgets, staffing, as well as driving to enhance a culture focused on customer satisfaction.  This position is an active member on senior management team and will provide input critical to the success of the overall business.

 

Essential Skills and Experience:

  • Bachelor of Science degree in Engineering/technical discipline; advanced degree (Masters, PhD) preferred.
  • 10 years of progressive experience in functional or program management in the field of medical device product introduction.
  • High personal work ethic, attention to detail, strong sense of urgency and ability to positively motivate team and other supporting resources.
  • Ethical leader who executes with energy, quality and commitment to the customer and company values.
   
   
 
 
 

Firmware Engineer

 

Our client, a leading manufacturer of software controlled medical devices, is looking for a Firmware Engineer. The position uses Design C language microprocessor software for internationally (including FDA) regulated lithotripsy and insufflation devices.


Duties and Responsibilities

  • Design, test and debug microprocessor based C language software in accordance with IEC 62304 Medical Device Software Processes and internal gate based development process.
  • Work with the interdisciplinary engineering team to partition product designs into testable, comprehensive requirements which will then be verified and validated prior to product release.
  • Document software architecture and design details using Word, Visio and Excel.
  • Follow CAPA guidelines in resolving post-release issues related to software design.
  • Implement an effective test and calibration environment via the use of LabView based programs operating in conjunction with the abovementioned C language software.
  • Understand the clinical procedures that constitute the end-use of devices and disposables.

 

Administration

  • Complies with all procedures and policies concerning quality, medical device regulations (ISO 13485, 21CFR820.30, 93/42/EEC, and CMDCAS).
  • Maintains responsibility for ensuring software procedures are up to date with standards and testing is performed in an efficient and comprehensive manner.
  • Guides the Risk Management, EN 62304 and FMEA activities with regard to software and its interaction with safety and regulatory aspects of the end product.
  • Is able to assume responsibility for small projects which may involve leading other engineers.
  • Establishes and/or maintains a safe work environment according to federal, state, and policies and OSHA if applicable.


Supplementary

  • Perform other work related duties and special projects as required.
  • Participate in ongoing training to maintain and update skill sets as
   
   
 
   
 
 

Chief Commercial Officer

 

Our client, a leading Global Healthcare Services company, is looking for a Chief Commercial Officer for North America.   This individual will be responsible for growing a small base to business in North America to rival their European counterpart.   They are a Direct to Consumer subscription base model which provides ability to store stem cells from children.  They are the first banking service that uses this method which is safe, simple, non-invasive and requires no medical intervention.  Their scientific procedure allows for the greatest potency and potential for therapeutic application allowing more treatment options. The reason for storing stem cells is the ability to save the child’s life or treat many diseases, growing replacement skin, new corneas, heart repair, and diabetes.    Their US facility is formally regulated by the FDA and has a fully controlled storage system.

 

The individual they are seeking will have a strong Digital Direct to Consumer experience and can come from a non-medical market.  They must have the ability to attract new customers, be a team builder and leader.   They will be required to build a cohesive sales/marketing team in Austin, Texas.  Also they will have a Director of Operations person reporting who controls the store facility in the US.

 

This is an opportunity to join a fast growing company and put your mark on the North American market place.

 

Job Summary/Purpose:

The main purpose of this role is to acquire, retain and grow the membership (customer) base, by devising and implementing customer acquisition strategies combined with product and service enhancements that deliver member benefits - resulting in outstanding value. In addition, the post-holder will be responsible for providing excellent customer support to members who use our services, ensuring member loyalty and delight. In addition the Chief Commercial Officer will be the company’s ‘brand champion’ and responsible for the website, tone of voice, narrative and general communications with the Membership base.

The ideal candidate will have a strong background in digital marketing, and demonstrable experience working in a membership organization, subscription-pricing model or in a role responsible for maintaining and growing the membership/customer base.

As a creative thinker and strong communicator, you will initiate relevant marketing activities, mostly in a digital environment, to increase awareness of services available, and educate people about member benefits.

To be successful in this role you will need to seek out and explore service development opportunities, ensuring innovation and dynamism in all your work, whilst ensuring the commercial viability of the business remains at the forefront of your thinking.

This is an opportunity to join a fast growing company and put your mark on the North American market place.

Responsibilities:

Responsible for developing the existing membership program.

  • Create compelling revenue generating products and services that gain interest and buy in, from new and existing customers.
  • Devise a value based offer that engages members.
  • Benchmark the provision of services for members in other organizations and propose/implement new services that are relevant, cost-effective and innovative.
  • Engage audiences in order to drive revenue and conversion, working with the Head of Sales to develop and run large-scale campaigns.
  • Support members to access services, recognizing issues, identifying causes and finding resolutions that improve the customer journey.
  • Ensure a high level of customer service is provided to our members, both directly and via other members of the team.
  • Conduct relevant analysis to identify the reasons for customer cancellations and execute solutions to increase retention.
  • Ensure membership documents and membership content are continuously updated and improved.
  • Develop private membership content on the website e.g. member’s portal to offer tailored offers and benefits.
  • Develop outreach programs as required by the business.

Skills, Experience and Knowledge

Essential:

  • Demonstrable experience in a direct to consumer membership organization or with a subscription-pricing model or in a role responsible for maintaining and growing the membership base.
  • Strong background in (new) business development and digital marketing.
  • Solid analytical skills with proven experience of conducting and analyzing audience research and reporting on key findings.
  • Excellent commercial, networking and interpersonal skills.
  • Experienced in implementing marketing strategies to a membership base.

Desirable:

  • Good level of computer literacy, including experience in the use of Microsoft packages (particularly, Outlook, Word, and Excel) and internal databases, such as a CRM.
  • Proven ability to provide wide-ranging and responsive customer service.
  • Ability to implement new strategies quickly, efficiently and effectively, identifying pragmatic solutions that can be developed and sustained.
  • Enthusiastic, confident and self-motivated individual, who can positively contribute to the organizations culture and ways of working.
  • Experience of working in co-operation and collaboration with colleagues to meet the goals of the team.
  • Experience of, or the intellect to grasp quickly, the broad dynamics of the US consumer market.

 

   
   
 
   
 
 

President

 

Our client, a leading European Pharmaceutical Services company with proprietary technology seeks a President to form a US division. This company has designed and patented a system which will change the way people take their medication. We are looking for a leader who can help us build a great company, with a great culture and a world class service.


Position
The President will report into the CEO and will work collaboratively with the Board of Directors in establishing the company’s North American operations, responsibilities include:


- Global sales and marketing strategy and execution,
- Customer acquisition management and support,
- US Operations, legal and financial management as required,
- Clinical development.


Responsibilities

  • Establish sales, marketing and customer support arm of the company.
  • Recruit excellent personnel and create a collaborative company culture.
  • Collaborate with the R&D and production teams, to refine and implement the Global sales, marketing and product launch strategic plan while managing budget, staff and priorities.
  • Establish strategic partnerships, to move the company’s business forward.
  • Refine and implement the company’s strategic plan while ensuring that the budget, staff and priorities for the company’s Global clinical development strategy including prioritizing and implementing clinical trials required for the marketing of their system.
  • Cultivate a strong and transparent working relationship and ensure open communication about the measurement of financial, programmatic, and impact performance against stated milestones and goals.
  • Strengthening infrastructure and operations
  • Ensure the delivery of high quality services while managing for current and future growth
  • Support and motivate the organization's staff
  • Facilitate cross-departmental collaboration and strengthen internal communications with staff throughout the organization; create and promote a positive, multicultural work environment that supports consistency throughout the organization's strategy, operational methods, and data collection needs

Qualifications

  • Minimum of a BA, ideally with an MBA or related advanced degree
  • Experience with working with a small/medium company
  • At least 10 years of Executive Sales and Marketing experience within pharmaceutical services/ technology
  • Leadership, flexibility and ability to innovate
  • A financially savvy and politically astute leader with the ability to set clear priorities, delegate, and guide investment in people and systems; keen analytic, organization and problem solving skills, which support and enable sound decision making
  • Excellent coalition building skills with an ability to communicate and work effectively with a variety of internal and external stakeholders; a persuasive negotiator able to achieve consensus amongst differing opinions
  • Outstanding presentation and communication skills and the experience and proclivity to be an outgoing spokesperson, relationship builder, and fundraiser
  • Strong commitment to the professional development of staff; successful track record of recruiting and retaining a diverse team
   
   
 
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Director, Healthcare Systems - Northwest Territory

 

Our client, a leading supplier of healthcare products and services, is currently seeking a Director, Healthcare Systems - Northwest Territory.

Responsibilities:

Position Summary:
The corporate strategic account Director position combines multiple functional attributes such as sales, business development, and marketing. The successful strategic account Director drives sales growth, develops account strategies, manages executive relationships, and improves overall customer satisfaction at their assigned corporate accounts. Increase sales by utilizing designated distributors and programs established by National Accounts. Acting as the single point of contact, develop and maintain relationships with national and key regional distributor sales leaders and top distributor reps within area. Specific job duties include. 


Essential Duties

  • Development and execution of the IDN strategy for IDNs & Strategic corporate accounts consistent with the business strategy.
  • Generates sales of existing and new products and solutions portfolio at their strategic corporate accounts.
  • Uses a high level of financial and business acumen to assess and cultivate new business and leveraged business opportunities.
  • Gains input and trend information from major customer groups through direct contact with such groups, organizations and other vendors.
  • Cultivates, promotes and maintains VIP relationships. Maintains a productive and beneficial relationship with influential executives.
  • Targets top/middle of customer continuum and calls on the “C” suite to build and maintain a relationship with the financially responsible party and key decisions makers at the account.
  • Demonstrates a deep understanding of the account and aligns resources, including Executive support to deliver a solutions based value proposition.
  • Provides leadership in the planning, designing, and implementing of strategic business objectives at strategic corporate accounts.
  • Defines vision, strategies and tactics required for profitable and sustained growth at strategic corporate accounts.
  • Provides competitive intelligence, input and trend information to management and marketing.
  • Accountable for price and contract negotiation.
  • Provides product input and feedback to marketing on behalf of the account.
  • Acts as Sales liaison.
  • Leads annual strategic corporate account review to discuss, SWOT and business plan 1 year and 3 years out.
  • Manages account planning across products/solutions and account administration.
  • Conducts quarterly business reviews with the account.
  • Lead/conduct QBRs and Annual Contract Reviews with clients
  • Develop and maintain relationships with key distributor sales directors.
  • Attend and manage key distributor regional and national sales meetings, insuring an overall presence at these meetings including the attendance of key company reps, Regional Managers, and Zone VPs.
  • Maintain key relationships with internal departments (i.e., Sales Contracting, Marketing, Technical Services, Customer Service, etc)
  • Drive consistent interaction field interaction with top distributor representatives and key distributor regional management teams.
  • Maintain a list of shared key account targets with distribution partners and update that list every 6 months.

Knowledge & Skills

  • Ability to use computer software such as email and the Microsoft Office Suite of products.
  • Strong understanding of customer base and business environment including experience with multiple large complex national customers.
  • Ability to develop relationships from C-Suite to factory floor.
  • Ability to lead multi discipline sales team.
  • Experience in consultative sales, with the ability to develop technical value propositions.
  • Strong prospecting skills
  • Ability to be a motivated self starter, capable of independent action and business savvy
  • Detail oriented.
  • Ability to multi-task with strong time management skills
  • Ability to internalize technical concepts, products and services
  • Strong oral/written communication skills
  • Strong conflict management skills,
  • Ability to generate proposals and value propositions.
  • Qualifications
  • A minimum of 2 years Sales Management experience with proven national scope experience & responsibility .
  • A minimum of a bachelors degree in a related discipline plus 10 years of experience OR a minimum of 10-15 years of directly related experience.
  • A minimum of 8 years experience managing sales accounts.
  • A minimum of 8 years experience in account development.
  • Excellent oral and written communication/interpersonal skills.
  • The ability to work non-standard hours and to travel upwards of 75%.'
  • Travel up to 75%
    Desired:
  • Relevant experience in prospecting new business development at key corporate accounts, both GPO and Distribution;
  • Ability to lead multi discipline sales team through a defined selling process; multi-level, high value, complex accounts.
  • Experience in consultative sales, with the ability to develop technical value propositions.
  • Ability to develop relationships from C-Suite to factory floor.
  • Experience in developing profitable sales opportunities, product knowledge (width not depth), identify develop and secure opportunities to deliver annual revenue plan, and negotiate annual pricing contracts.
   
   
 
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Director of Operations

 

Our client a leading Pharmaceutical company seeks a Director of Operations to direct all manufacturing operations including Product and Maintenance to ensure facility meets Quality and Safety stands, required timelines are completed within operations budgets. This person will lead a three shift 24/7 operation with 350 employees.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

  • Plan, develop and implement strategies to improve and standardize all aspects of Operations. Ensure consistency between shifts and departments in application of policies and procedures.
  • Ensure a safe working environment and promote safe work practices in the Operations Team.
  • Responsible for compliance of plant operations with all company policies and the applicable federal, state and local regulations, including OSHA, FDA and employment law.
  • Direct all Operations activities to manufacture and deliver a quality product, on time, to specification at the least reasonable cost to meet customer needs.
  • Partner with Production Planning and Scheduling to coordinate the short- and long-term operations schedule based on sales requests, demand capacity and customer service. Review operational performance to ensure lines are performing according to plan and adjust accordingly.
  • Plan, monitor and analyze the Operations budget and expenses; taking corrective action as necessary to implement improvements and/or control costs.
  • Drive volume growth and productivity improvements by supporting Lean and Performance Excellence initiatives to enhance customer service and profit improvement.
  • Review workforce utilization and conduct workforce analysis to ensure the appropriate headcount and skill set to deliver on customer commitments.
  • Select, lead, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition.
  • Engage the workforce to build a culture of safety, quality and operational discipline to ensure we meet our goals and objectives.
  • Direct the Training and Development of the Operations team including cross-training initiatives and effective on-boarding of new hires or transfers/promotions to the team.
  • Ensure Operations SOP’s and WP’s are accurate and effective; partner with appropriate departments to modify, add or delete current practices, as appropriate.
  • Partner with Business Units, Engineering, Validations, etc. to ensure new product launches are successful.
  • This position may require overtime and/or weekend work.
  • Attendance to work is an essential function of this position.
  • Perform other duties as assigned.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:
Bachelor's Degree in a related field and/or 10+ years related experience and/or training.
College Level Mathematical Skills

Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred:

• Previous experience in a cGMP environment
• Lean, Continuous Improvement, Six Sigma
• Strong Leader
• Be collaborative
• Have emotional intelligence
• Own quality from an operational perspective
• Have P/L experience, have influence on top and bottom lines
• Be able to galvanize a workforce and inject positive moral while driving operational

   
   
 
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Business Development

 

Our client, a funded Digital Heath start-up company is seeking a Business Development professional to launch the company’s offering to the pharmaceutical industry and create a large deal pipeline. The successful candidate will be able to advance opportunities in formal pharmaceutical organizations while working in an entrepreneurial company environment.

This start-up company is supporting pharmaceutical companies with beyond-the-pill capabilities adapted to specific drugs. By offering a total technology and service platform they are helping to create patient preference, better data, and better outcomes ultimately improving clinical trials and increasing fills and gaining greater share of prescriptions of marketed medications.

At the core of the company learning medication management system is the ability to safely deliver and track each pill from manufacture to the patient’s mouth, providing real-time adherence data along the way. The company has established a robust IP position and proof of concept demonstration products.

Implemented in scale, the company learning medication management system opens new treatment opportunities to provide truly personalized medicine. Reliable drug intake information can be used to improve compliance through personalized programs for each individual. Compliance programs can be continually tested, evaluated and optimized to determine the best outreach mix for each person. Flexible and complex drug regimens can be remotely monitored and changed while using real-time patient feedback surveys and telemedicine to ensure safe treatment.

   
   
 
   
 
 

Director of Operations

 

Our client, a leading manufacturer of specialty epoxy coating used in hospitals, construction, and food processing, seeks a Director of Operations.  This person must have strong manufacturing, quality, and continuous improvement experience.

 

Job Summary: 

 

Plans, organizes, directs, controls, and coordinates the operational activities and resources necessary for manufacturing.  These activities are to be performed in accordance with the highest standards of safety and quality, and provide the input and support necessary to achieve business objectives.  Responsibilities cover the functions of Manufacturing, Process Engineering, Shipping and Receiving, Sourcing/Purchasing, Quality, Environmental, Scheduling, and Inventory Management.  This professional will abide by the core values of the company and be a positive motivating influence in the organization.  This professional will have an extensive understanding of lean manufacturing processes and have a “hands-on” role that will champion continuous improvement initiatives.

 

Duties and Responsibilities:

 

Creates and implements the long-term Operations strategy based upon best practices and standardized policies and procedures within functions.

  • Creates and monitors measurable key productivity indicators for Quality, Productivity, Cost and Safety and any other indicators which are critical to the success of manufacturing.
  • Actively engages in Lean Management by encouraging, teaching, participating in, and supporting the Lean Six Sigma culture and tools.
  • Manages the manufacturing staff and related functions at the facility to ensure production is timely and cost effective.  Ensures balance is maintained across functions for proper execution of responsibilities in a professional environment.
  • Effectively interacts with cross-functional groups including sales and marketing, R&D, engineering and quality.
  • Supports new product transition for all new products in development, including early pilot builds, design for manufacturability recommendations, service strategies, etc.
  • Supports ongoing safety program in the performance of all tasks and promotes safety in all areas of responsibility including roll out of enhanced initiatives (i.e., physical audits, etc.)
  • Ensures the company is in compliance with all state and federal environmental regulations.
  • Ensures that production schedules are in accordance with company objectives and customer demands.
  • Reviews production operations, applying knowledge of production processes and methods, machine and equipment capabilities and staffing requirements, to produce quality products.
  • Reviews operating results as they affect production cost, making specific recommendations to result in cost reduction and profit improvement.
  • Establishes and implements related methods and procedures.
  • Ensures that all departments within responsibility are operating at peak performance.
  • Manages, develops, trains, coaches, and evaluates the members of the operations team.  This includes conducting annual performance appraisals for all direct reports.
  • Provides advice and counsel to senior management regarding manufacturing.
  • Administers the capital budget process, including the development of annual capital plans and budgets, and execution of strategic capital projects in support of operations.  Prepares and delivers presentations of capital plans and projects as required.
  • Establishes and administers the global asset plan for the company/
  • Leads the Lean Six Sigma and continuous improvement initiatives for the company and must be knowledgeable in the effective use of Lean Six Sigma (LSS) tools and concepts to assist in process improvements, both within the company, and externally at the customers/suppliers.
  • All other duties as assigned.
  • Must adhere to all company policies and safety rules.
  • Must be able to work extended hours when required.

 Education, Experience, Skills and Abilities Required for Consideration as a Candidate:

  • Bachelor degree in Management, Engineering or related area
  • Seven to ten years of experience in multi-product manufacturing setting working with chemicals, adhesives and/or coatings
  • Must have minimum of three years supervisory experience
  • Must have experience working in small to mid-size companies in manufacturing capacity
  • Experience with Lean Six Sigma and Lean Manufacturing required
  • Must be Green certified or its equivalent
  • Must possess strong verbal, written, and interpersonal skills
  • Must demonstrate strong leadership skills.

Education, Experience, Skills and Abilities Preferred:

  • MBA or equivalent
  • Black Belt certified
  • Project Management Training
  • One to three years experience with ISO 9001
Willingness to travel away from home for more than one day
   
   
 
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Director of Sales & Marketing

 

Our client, a well known manufacturer of manufacturer of imaging and software products for the Cardiovascular area seeks a Director of Sales & Marketing.

 

Position Summary:

The Director of Sales and Marketing is responsible for the direction and management of all sales and business development operations, including revenue generation, market competiveness, strategic customer relationship and development, and distribution and sales channel activity.  The position includes responsibility for the development and growth of a national and international sales team.

Position Responsibilities:

Oversee the development of sales opportunities for medical device hardware and software products and services:

  • Manage independent representatives
    • Increase and develop the existing network of independent sales agents.
    • Develop territory goals.  Provide training, sales support and regular follow-up.
  • Develop and manage distribution channels for product sales and service
    • Develop strategy to develop domestic and international 3rd party distribution channels. Identify opportunities; negotiate distributor agreements.
    • Identify training and sales support needs to ensure successful distribution channels. Coordinate installation and service support.
    • Develop consumable and service sales opportunities for new and existing products.
  • Direct sales
    • Develop sales plans and territory strategies to meet sales objectives.
    • Coach sales specialists on their solution strategies and offerings.
    • Attract, hire, train, develop, evaluate, motivate and manage members of the sales and marketing team.
    • Target new business accounts and opportunities for new and existing customers.
    • Lead development, qualify customer funding, prepare quotes, and close.
  • Marketing
    • Develop business intelligence to identify areas of growth and opportunities to gain market share.
    • Develop price lists and product configuration strategies.
    • Develop and maintain strong relationships with strategic customers.
    • Oversee the development of marketing collaterals.
    • Establish and oversee customer relationship management system (CRM).
    • Oversee e-commerce and company websites.
    • Accurately forecast direct and distributor sales.
    • Establish trade show presence; coordinate all related logistics.
  • Product development
    • Collaborate with Clinical Application Specialists to define new product requirements.
    • Interface with product management to prioritize new product development activities.
    • Identify and support research customers.

Essential skills and experience:

  • Bachelor’s degree in business, marketing or related field, or the equivalent experience plus 10-12 years’ of related experience.
  • 3-5 years’ experience working in, or interfacing with, clinical applications.
  • 3-5 years’ experience in selling medical product to hospitals, clinics, or private practices.
  • Highly developed organizational, planning and management skills.
  • Proven experience in building sales channels and teams.
  • Positive attitude with high energy and high degree of integrity. 
  • Strategic thinker with ability to develop business plans and manage multiple priorities.
  • Solid knowledge and proficiency with MS Office; Outlook, Excel, Word, etc.
  • Excellent interpersonal and communication skills; strong team player.
  • Drive to succeed with a strong commitment to quality and a willingness to do what it takes satisfy the customer. 
  • Must be able to travel approximately 25% of the time.
   
   
 
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Cinical Buisness Development Manager

 

Our client, a leading Contract Manufacturer and Packager of Pharmaceutical products seeks a Clinical Business Development Manager for the West Coast.

 

Responsibilities:

  • Develop and close new business opportunities for Phase I/II projects in assigned Territory.  Currently this territory includes the West Coast (CA, OR, WA, BC), but temporary support may be needed in other areas of the western US.
  • Growing existing clinical contract manufacturing sales
  • Clinical account management (if applicable).

Tasks:

  • Identifies and qualifies prospective companies within Territory to determine target list and update regularly
  • Prepare quotes for prospective customers.
  • Facilitate and negotiate confidentiality agreements and development agreements with potential clients in conjunction with company’s legal department
  • Actively promote the company through social media, industry associations, and trade shows
  • Calls on biotechnological and pharmaceutical companies and re-contacts leads regularly
  • Creates and cultivates common Lead Data Base
  • Develops new business opportunities and demonstrates active customer interaction
  • Develops active relationships with relevant consultants
  • Seek out new channels to network and cultivate new leads and promote the company.  Need to be an active “hunter” for new business.
  • Identifies and exhibits/speaks at trade shows and relevant industry events

Minimum Requirements:

  • Technical Degree (B.S. or M.S.) in an applied science or engineering field and at least 3 years of selling experience in the technical pharmaceutical industry. Experience in aseptic pharmaceutical manufacturing and packaging.
  • Knowledge of the specific needs and requirements of a contract development and manufacturing organization English fluency required.  Knowledge of German beneficial.
  • The person needs to reside in California

 

   
   
 
   
 
 

Sr. Manager/Director Marketing Communications

 

Our client a leading manufacturer of Medical products seeks a Sr. Manager/Director Marketing Communications.

 

The Sr. Manager/Director Marketing Communications is responsible for the Company’s communications and branding output (online/print/promotional/events), with oversight of the creative process utilizing internal and external creative resources.  This position will assign tasks and projects to internal resources and external agency staff, and will also execute projects independently.

 

The Sr. Marketing/Director Marketing Communications will play a key role developing the Company’s creative strategy by aligning internal and external resources to assure top-quality brand management.  The Sr. Marketing/Director Marketing communications supervises others and is responsible for assigning work and managing performance.

 

Duties and Responsibilities

  • Plans, develops and drives communications programs based on business strategies that align with the Company’s overall positioning.
  • Manages the media outlets, maintains advertising and e-marketing schedules.
  • Manages creative content of all marketing materials and programs, including graphic design and copy.
  • Manages the Company’s Websites, e-marketing and social medial programs.
  • Oversees key Company events including tradeshows, corporate meetings and customer events.
  • Develops project plans to assure alignment with all internal and external resources.
  • Interfaces with internal customers and manages creative resources to ensure efficient delivery of marketing projects; takes on projects independently when required.
  • Guides the development, evolution, communication and implementation of brad standards; this includes accountability for brand consistency across online/offline campaigns.
  • Facilitates the ability for the designers to produce superior creative work that meets business objectives, brand standards and usability best practices.
  • Develops creative brief and execution plan for assigned projects to assure the design team clearly understands the deliverable expectations.
  • Manages outside advertising agencies and other creative resources; secures project estimates, reviews billing, and oversees workflow.
  • Provides quality control, including proofing/editing.
  • Evaluates agency performance, creative output and project processes.
  • Identifies additional resources needed and recommends the approach, i.e., freelance or full time.
  • Supervises numerous projects, activities and deadlines simultaneously.
  • Stays abreast of product portfolio, orthodontic/dental industry trends and competitive activity.
  • Supervises and guides direct reports, providing leadership and career growth plans through solid performance management.
  • Serves as Inside News editor.
  • Assists the International Distribution Centers in adopting/implementing market-specific programs through the use of same or similar digital assets.
  • Other duties and responsibilities as assigned. 

Knowledge and Skill

  • BFA/BA/BS degrees, required
  • Superior communication skills, both written and verbal
  • Five or more years of leadership experience
  • Strong project management skills
  • Experience with developing and executing offline and online marketing programs
  • In-house and agency creative services experience
  • A thorough understanding of current design and projection software and emerging design trends
  • Must have innate ability to work independently and as part of a team, and at times with limited supervision

Software knowledge required for this position:

  • Proficiency in Microsoft Word, Excel, Outlook, PowerPoint
  • Understanding of CRM programs and ability to learn the Company’s custom program.

Problem Solving/Decision Making

 

While workload/projects are assigned by senior management, the Marketing Manager should have an extensive background in a broad range of content creation roles, with a proven ability to prioritize, thrive in a dynamic creative environment, and oversee multiple projects at once.  Often times, the Marketing Manager will facilitate “brainstorming” sessions in order to gather new/fresh ideas and content.  The Creative Services Manager also needs to have the ability to work independently and at times with limited supervision.

  • Understand strategic brand position and be able to identify areas needing improvement.
  • Ability to interact with senior management to understand and interpret business requirements for the creation of dynamic internal and external print and digital design solutions.
  • Ability to interact with high-value customers and KOL’s to gain industry insight.
  • Ability to judge creative concepts and copy, and clearly communicate creative direction to others.
  • Thorough understanding of art direction required. 
   
   
 
   
 
 

Director R&D/Product Development

 

Our client a leading manufacturer of Medical Products seeks a Director R&D/Product Development.

 

This position is responsible for managing and leading engineering and quality teams while meeting project goals, deadlines and budgets. Responsible for coaching, motivating and mentoring the team members to draw out the best possible work products. This individual will be accountable for conceptualizing, designing, developing, testing and releasing new products in support of business growth strategy and objectives. The position requires working closely with our customers, suppliers and our manufacturing group to design products that provide the best solutions for our customers.

  • Minimum of Bachelor of Science in Mechanical Engineering or Mechanical Engineering Technology or other suitable discipline and/or;
  • Five or more years’ experience in research and development in a manufacturing environment, including product development and testing.
  • Five years supervisory experience of technical personnel.
  • Advanced proficiency in SolidWorks, MasterCam, or equivalent CADD software.
  • Ability to design and develop product, preferably in a medical device manufacturing environment.
  • Strong communication skills; ability to interact with departmental leaders to effectively present ideas and information on project management.
  • Excellent organizational skills and attention to detail; ability to multi-task effectively.
   
   
 
   
 

 

Corporate Strategic Account Director

Our client, one of the Top 20 Medical Device companies in the world seeks a Corporate Strategic Account Director to handle IDN Sales in the Midwest.

Position Summary:

The Corporate Strategic Account Director position combines multiple functional attributes such as sales, business development, and marketing.  The successful Strategic Account Director drives sales growth, develops account strategies, manages executive relationships, and improves overall customer satisfaction at their assigned corporate accounts.  Increase sales of the overall company portfolio within Targeted Strategic Accounts utilizing designated distributors and programs established by National Accounts.  Acting as the single point of contact, develop and maintain relationships with national and key regional distributor sales leaders and top distributor reps within area. 

Responsibilities / Essential Duties: 

  • Development and execution of the IDN strategy for IDNs & Strategic corporate accounts consistent with the company’s business strategy. 
  • Generates sales of existing and new products and solutions portfolio at their strategic corporate accounts. 
  • Uses a high level of financial and business acumen to assess and cultivate new business and leveraged business opportunities. 
  • Gains input and trend information form major customer groups through direct contact with such groups, organizations and other vendors.
  • Cultivates, promotes and maintains VIP relationships.  Maintains a productive and beneficial relationship with influential executives.
  • Targets top/middle of customer continuum and calls on the “C” suite to build and maintain a relationship with the financially responsible party and key decisions makers at the account.
  • Demonstrates a deep understanding of the account, including Executive support to deliver solutions based value proposition.
  • Provides leadership in the planning, designing, and implementing of strategic business objectives at strategic corporate accounts. 
  • Defines vision, strategies and tactics required for profitable and sustained growth at strategic corporate accounts.
  • Provides competitive intelligence, input and trend information to management and marketing.
  • Accountable for price and contract negotiation.
  • Provides product input and feedback to marketing on behalf of the account.

Ideal candidate will have minimum of 5-10 years sales, sales management, national accounts, IDN experience within the Medical Device field. 

  • Manages account planning across products/solutions and account administration.
  • Conducts quarterly business reviews with the account.
  • Develop and maintain relationships with key distributor sales directors.
  • Attend and manage key distributor regional and national sales meetings.
  • Drive consistent interaction field interaction with top distributor representatives and key distributor regional management teams.

Desired Qualifications / Experience:

  • Relevant experience in prospecting new business development at IDN key corporate accounts, both GPO and Distribution.
  • Ability to lead multi discipline sales team through a defined selling process; multi-level, high value, complex accounts. 
  • Experience in consultative sales, with the ability to develop technical value propositions.
  • Ability to develop relationships from C-Suite to factory floor.
  • Experience in developing profitable sales opportunities, product knowledge (width not depth), identify develop and secure opportunities to deliver annual revenue plan, and negotiate annual pricing contracts. 

Compensation will include an excellent base, bonus program along with company car and all expenses. 

   
   
 
   
 
 

CEO

Our client, a well-known billion dollar Chicago based Venture Capital firm is seeking a CEO with Healthcare, Biotech or Pharmaceutical experience.  This person will add to their bench strength which will allow them to buy or build a company around the successful candidate.  The individual they are seeking has a proven pedigree, a track record of building successful companies, and growing profitability. 

This Venture Capital experience allows them to add value to their portfolio companies through strategy development, operational guidance, and sharing of best practices.  In addition they assist with financing, acquisition and other capital market transition to improve profitability and revenue.  They look to invest $20 million to $300 million equity in each opportunity.

The successful individual will have managed a company with $10 million - $100 million in revenue with EBITDA of $5 million - $25 million range.  They are looking to build relationships with executives who can be value-added partners.

   
   
 
 

 
   
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