Jobs in Huntington Beach, CA

About the role

The Principal Manufacturing Engineer leads cross-functional collaboration with R&D, Quality, and Supply Chain teams, as well as external partners, to elevate tooling and component quality and deliver sustained cost reduction. Beyond hands-on process ownership, this role carries significant technical leadership responsibilities, mentoring junior engineers, leading high-impact improvement initiatives, and contributing to the manufacturing strategy that supports the long-term commercialization of our device.

What you'll bring

• BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering
• 8+ years of engineering experience with advanced skills in process development, Manufacturing Engineering, and industrialization
• Deep expertise in process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs, with a proven track record of owning and leading validation programs end-to-end
• Comprehensive knowledge of medical device quality regulations including ISO 13485 and FDA quality system regulations, with experience supporting regulatory submissions and audits
• Advanced problem-solving skills
• formal project management training or certification (e.g., PMP) is an advantage
• Demonstrated experience leading cross-functional engineering projects and mentoring junior engineers
• formal or informal people leadership experience is highly regarded
• MS desirable (or equivalent experience)
• medical device or highly regulated industry experience strongly preferred
• Six Sigma Black Belt strongly preferred

Benefits