Manufacturing Mechanical Engineer IV
$130,000–$153,000 year
On-siteHuntington Beach, California, United States
Huntington Beach, California, United StatesOn-siteFull Time$130,000–$153,000 yearSenior LevelBachelors DegreeSmall
Full TimeSenior LevelBachelors DegreeSmall
Job Summary
Senior Manufacturing Engineer IV leading the design, development, and continuous improvement of manufacturing processes for the BiVACOR Total Artificial Heart at the Huntington Beach, CA headquarters. Serves as SME in value engineering and advanced manufacturing; drives Lean/Six Sigma initiatives, automation, equipment validation, DFM, and regulatory readiness (FDA, ISO 13485, GMP). Mentors junior engineers, leads cross-functional projects, and contributes to manufacturing strategy and technology transfer.
Required Qualifications
- BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering
- 8+ years of engineering experience
- medical device or highly regulated industry experience strongly preferred
- experience with process development, Manufacturing Engineering, and industrialization
- knowledge of ISO 13485 and FDA quality system regulations
- IQ/OQ/PQ/PPQ validation experience
- Six Sigma Black Belt strongly preferred
- PMP or project management certification advantageous
Desired Qualifications
- MS desirable
- Six Sigma Black Belt strongly preferred
- PMP or project management certification advantageous
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