Medical Device Engineer

Supporting analyses of medical device degradation, the full-time salaried Medical Device Engineer or Materials Scientist will provide scientific and technical consultation related to regulatory reviews and product development for implantable medical devices, working 100% remotely. Key responsibilities Support analyses of medical device degradation in relation to regulatory and technical aspects Provide consultation for medical device reviews including EUA, 510(k), PMA, and related submissions Develop written reviews, correspondence, and detailed reports Required qualifications Advanced degree (MS, PhD) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or equivalent Demonstrable expertise in degradation (fretting, wear, corrosion) of implantable medical devices Experience with mechanical and chemical performance testing of orthopedic and cardiovascular implants 10 years of experience in medical device engineering and/or materials science Experience supporting FDA 510(k) and related regulatory submissions