Provide oversight to development teams with respect to implant and instrument design work. Assist in segments of complex multi-functional teams to advance assigned projects through the design/development process and ultimately through launch into the market by championing the use of best practices. Educate engineers on Stakeholders perspectives. It is an individual contributor role.
Essential Duties & Responsibilities:
- Provide technical oversight throughout the New Product Development Process (NPDP). Work with Program Managers and mentor technical teams to ensure the appropriate level of design rigor is applied within the scope of the NPDP guidelines.
- Review and approve R&D technical documents used in design verification and health risk management. These include test protocols, technical reports, engineering analyses, and failure mode and effects analyses.
- Identify and approve design performance requirements for orthopedic implants and surgical instrumentation systems.
- Provide guidance in conducting and evaluating design verification and validation activities to comply with internal standards and regulations. Assure that the appropriate amount of experimental rigor is applied in engineering decision making.
- Interface with clinical advisers and Research Directors to gather input for design and evaluation of new products. Participate in design validation labs, including cadaveric labs, and consultant panel meetings.
- Review and approve design models generated using Pro/Engineer design software.
- Represent the Product Development position when interfacing with business partners, including Quality Assurance, Regulatory Affairs, Marketing, and Operations.
Qualifications and Work Experience Required
- BS in Engineering (Mechanical or Biomedical Engineering, Advanced degreepreferred)
- 10+ years of product design experience in orthopedics or the medical device industry.
- Expertise in design controls and risk management within a regulated industry.
- Ability to influence, educate and mentor on areas of expertise.
- Expertise with a parametric CAD design package, (Pro/Engineer preferred).
- Expertise with Finite Element Analysis (FEA) and its application.
- Expertise leading multiple complex product development initiatives, from concept through release.
- Demonstrated ability to effectively communicate engineering principals to all levels within the organization through oral and written means.
Work From Home: NoTravel Percentage: Up to 25%