R&D | Engineering | Quality

4 weeks ago

Westlake Village CA, United States BioTalent Full time

R&D Sustaining Engineer | Medical Devices Location: Westlake Village, CA (100% Onsite)
Compensation: $100k–$120k + bonus + benefits
Employment: Full Time
(This role is not eligible for visa sponsorship.)

Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.
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 Do
Lead sustaining engineering projects focused on product improvements, cost reductions, and component updates
Serve as a primary R&D partner to Manufacturing for troubleshooting and root cause analysis
Implement and document design & process changes in compliance with regulated environments
Support V&V testing, documentation, and engineering evaluations
Contribute to change orders, labeling/IFU updates, and competitive product testing

What You Bring
~ Bachelor’s degree in Mechanical, Biomedical, Electrical , or related engineering field
~4+ years in a regulated industry; medical device experience strongly preferred
~ Understanding of FDA, ISO, and GMP requirements
~ Experience with design controls, risk management, and validation
~ Strong problem-solving and project leadership skills
~ Proficiency with SolidWorks and Microsoft Office / MS Project
~ Familiarity with lean manufacturing or continuous improvement methodologies

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