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Senior Product Development Engineer
The Senior Product Development Engineer leads or plays a prominent role in the development of medical device projects from conception, design and development of new products and their processes using design and development systems in accordance with FDA and international regulations.
- Leads or plays a prominent role supporting major projects, or phases of projects, to resolve advanced and complex technical problems.
- Leads or plays a prominent role supporting product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing.
- Authors and executes product and system specifications, validation and test protocols and validation and test reports.
- Leads or plays a prominent role supporting Risk Management activities including, Fault Tree Analysis and Failure Mode and Effects Analysis activities to ensure design, use, and process shortcomings are identified and appropriately addressed.
- Works with Quality Assurance to maintain an approved Quality System that complies with GMP’s, QSR and ISO standards.
- Maintains the DHF throughout a product’s lifecycle.
- Creates and carries out regulatory strategies and pathways for EU and FDA submissions.
- Makes prototype products / fixtures either by direct use of machining equipment or by directing outside suppliers with appropriate drawings.
- Builds test equipment, conducts testing of product, and analyzes data as needed.
- Assesses reliability, safety, performance and risk of new designs and methodologies and insures individual and group safety when conducting all activities.
- Supports manufacturing activities, as necessary.
- Supports the regulatory team in drafting 510k submissions for market clearance.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES
- A bachelor’s degree in Engineering and 6-8 years of experience in a medical device development environment OR an equivalent combination of education and experience is required.
- At least 6 plus years’ experience with medical device regulatory environments, especially in the US and EU is required;
- At least 6 years’ experience with ISO and QSR regulatory environments is required.
In addition, should possess:
- A strong understanding of product and process development of medical devices.
- The ability to work independently and in a team setting with demonstrated experience working cross-functionally and leading teams to accomplish goals.
- The ability to manage complexity in a fast-paced environment.
- An advanced understanding of the entire development process, including specification, documentation and Quality Assurance.