Essential Job Functions: · Design and develop medical devices and related accessories. · Develop and execute engineering tests, including benchtop, verification & validation (V&V), and pre-clinical studies. · Create comprehensive protocols and reports. · Develop tools, jigs, and fixtures to support prototyping, manufacturing, and testing. · Create preliminary sketches and detailed design concepts, perform measurements, analyses, and create engineering prototypes. · Communicate project status, risks, and opportunities to project team and management.
Contribute to the intellectual property base of the Company via active idea generation and communication of new concepts to management. · Assemble product drawings, specification, risk analysis and necessary technical documents. Ensure proper documentation of product designs within Design Dossier and Design History File (DHF) for regulatory compliance and filing purposes. · Contribute to product transfer and scale-up activities. · Ensure compliance with quality system procedures, all applicable federal, state, and local regulations, as well as company policies related to Health, Safety, and Environmental practices. · Maintain R&D laboratory to facilitate efficient prototype and process development. · Manage direct or in-direct report(s) as required. · Other general office duties as required.
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