The R&D Project Manager will actively interface with engineers, surgeons, and the company’s executive management team to develop project plans and associated budgets, lead project teams, identify and mitigate risks, and track and report progress on assigned projects. This individual will develop concepts, drawings, and prototypes for new products, and will also work with suppliers to build prototypes and/or test models, and may also interface with other company personnel and product development resources as necessary.

Essential Duties and Responsibilities:

• Lead the product development of medical devices following the appropriate standards as per Federal Drug Administration’s Design Controls 820.30 and appropriate international standards;


• Develop and coordinate files and content for regulatory submissions (e.g., IDE, 510(k), De Novo, PMA, etc.);


• Develop and communicate project plans, manage team communications, drive activities and task allocations, and promote team collaboration;


• Develop and establish design specifications based on user needs through market research activities such as voice of customer interviews and surveys;


• Develop prototypes and test protocols that conform to the applicable standards based on the intended uses of the products under development;


• Evaluate the performance and associated risks of products under development;


• Interface with surgeons, customers, suppliers, contractors, investors, and other internal and external constituents;


• Lead the design of, and participate in, pre-clinical animal and cadaveric evaluations to attain design inputs, resolve issues, and conduct final product evaluations;


• Develop, write, and review Standard Operating Procedures (SOPs);


• Prepare and lead project design reviews;


• Assist in the maintenance and enhancement of the company’s quality system;


• Support the development of production processes;


• Think creatively, problem solve, and develop innovative solutions based on sound engineering skills and statistical analyses;


• Travel to customers, vendors, and other locations (required 10-20%), including potential international locations; and


• Perform other tasks as may be required from time to time.

Essential Education, Skills, Environment Education and Work Experience:

• Degree in Engineering (Mechanical, Chemical or Biomedical preferred);


• Master’s Degree in and 3-5 years’ experience in product development (Medical Device Industry experience is preferred) or Bachelor’s Degree in Engineering and 5-7 years’ experience in product development;


• 3+ years of leadership roles in project management, Project Management Professional (PMP) certification a plus;


• 5+ years of product development experience, preferably in the medical device industry;


• Working knowledge of CAD systems (SolidWorks and Inventor), and preferably prior FEA experience;


• Prior experience in the design of biomaterials highly desired;


• Proficiency in understanding and applying of design controls, and their development;


• A strong understanding of manufacturing processes using state of the art technologies; and process improvement techniques (Six Sigma Green or Black Belt preferred).

Specialized Knowledge and Skills:

• The ability to lead multi-cultural, multi-discipline teams in developing medical products;


• The ability to develop and effectively manage project timelines independently or within a project team;

• The ability to maintain design control documentation, budgets, and project files;


• The ability to develop and perform product testing to include mechanical and physical testing and finite element analysis;


• The internal motivation and ability to personally drive a project and gain support from various required resources from within and outside of the company;


• The ability to build positive relationships inside and outside the Company, and to effectively communicate project status that might affect related research and development work for other programs; and


• The willingness to do assist in all necessary areas to achieve success.