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Job Title: Vice President, Product Development and Program Management
Location: Boston Area
Industry: Life Sciences

Responsibilities and Qualifications:

Our client, a metabolomics company developing clinical diagnostic tools for personalized medicine, is seeking a Vice President of Product Development and Program Management to lead their new product design and development efforts.

The Vice President of Product Development and Program Management is responsible for the direction of all product development and program management activities within Molecular Biometrics, Inc. Reporting to the Chief Operating Officer, the Vice President will serve as a member of the senior management team for the company and will work closely with the Senior Vice President of Sales and Marketing and the Vice President, Chief Scientific Officer.

Qualifications Include:

• Minimum of 10 to 15 years of medical device experience within the product development function, including a minimum of 5 to 10 years of leadership experience.


• Experience with instrumentation and consumable product development and systems integration is required.


• Solid understanding of design controls and FDA regulations relating to medical device product development and manufacturing transfer.


• Strong ability to lead successfully in a highly matrixed work environment. Able to build consensus and drive results across different functions of the organization.


• Strong working knowledge of the current global regulatory environment for medical devices (e.g. ISO-13485 and cGMP). Work closely with Regulatory Affairs and QA in making sure that all products are designed to meet US and international regulatory requirements.


• Knowledge of software development processes in the context of system development is also desired.


• Solid understanding of analytical validation procedures for medical devices.


• Ability to examine new product opportunities and identify strengths and weaknesses of these opportunities within the company’s strategy.


• Experience presenting to external audiences including Board of Directors, investors and potential partners.


• MS/PhD in an engineering or scientific discipline is required.