Manager, Manufacturing Engineering
$142,000–$177,000 year
Hybrid · San Diego, California, United States
Job Summary
Lead Manufacturing Engineering for infusion-set production with responsibilities spanning sustaining and new development, including product-cost reduction, automated/manual assembly technique development, and transfer of new processes to manufacturing. Direct/manage process development and validation protocols (DOE, IQ/OQ/PQ), design and debugging of test fixtures, and collaboration with R&D, QA, and suppliers. Drive continuous improvement via Kaizen, Lean, and Six Sigma; develop production test plans, BOMs, and manufacturing documentation; support packaging, production transfer, and pilot builds; mentor engineers and technicians; and ensure compliance with QSR/GMP/ISO requirements while delivering cost targets. This role combines leadership of a manufacturing engineering team with hands-on optimization of processes and equipment to improve manufacturability and throughput, with a base pay range of $142,000-$177,000 and a comprehensive benefits package. The position is Hybrid in-office at the Barnes facility in San Diego, CA, USA.
Required Qualifications
- B.S. degree in Science or Engineering or related field
- 8 years experience in medical device manufacturing
- 3 years experience managing/leading manufacturing engineering staff
- Experience in FDA/GMP/ISO environment
- Lean Manufacturing and 6 Sigma experience
- Project Management experience
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