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Senior Product Development Engineer
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Full-time
- As a key member of our Drug Delivery Programs team, the successful Senior Product Development Engineer is responsible for providing mechanical design engineering technical leadership on cross-functional product development teams during the pre-concept, development, design, test and documentation for manufacture of new and improved disposable medical and surgical devices, instruments or related products.
- The Senior Product Development Engineer is responsible for comprehensive technical knowledge of combination medical device development, transfer to manufacture, and supporting the regulatory approval process.
- Senior Product Development Engineer will have previous direct experience in the complete development life cycle from feasibility through commercialization and a strong character to drive projects to completion.
- Responsible for the development of medical devices through planning, development, test, verification, optimization, human factors, clinical validation, transfer to manufacture, and familiarity with the regulatory approval process (concept to commercialization).
- Directs contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.e., 510k, De Novo 510K and PMA).
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