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R&D Sustaining Engineer
4 weeks ago
R&D Sustaining Engineer | Medical DevicesLocation: Westlake Village, CA (100% Onsite)Compensation: $100k–$120k + bonus + benefitsEmployment: Full Time (This role is not eligible for visa sponsorship.)We are seeking an R&D Engineer who thrives in solving problems, improving products, and collaborating cross-functionally. This role focuses on supporting and improving existing medical device products — ensuring they remain reliable, compliant, and cost-effective throughout their lifecycle.You’ll work closely with Manufacturing, Quality, Supply Chain, and Regulatory teams to troubleshoot issues, implement design changes, and drive continuous improvement efforts.What You’ll DoLead sustaining engineering projects focused on product improvements, cost reductions, and component updatesServe as a primary R&D partner to Manufacturing for troubleshooting and root cause analysisImplement and document design & process changes in compliance with regulated environmentsSupport V&V testing, documentation, and engineering evaluationsContribute to change orders, labeling/IFU updates, and competitive product testingWhat You BringBachelor’s degree in Mechanical, Biomedical, Electrical, or related engineering field4+ years in a regulated industry; medical device experience strongly preferredUnderstanding of FDA, ISO, and GMP requirementsExperience with design controls, risk management, and validationStrong problem-solving and project leadership skillsProficiency with SolidWorks and Microsoft Office / MS ProjectFamiliarity with lean manufacturing or continuous improvement methodologies
