Sustaining Engineer will support operations and products for a highly regarded medical device development site in Irvine. CA. The Sustaining Engineer will ensure compliance of quality engineering principles and methods in the development of Class III medical devices. The Sustaining Engineer will work with both internal and external manufacturing sites.
- 4+ years experience in medical device manufacturing
- Bachelor's degree in engineering, advanced degree a plus
- Quality engineering experience in the medical device industry
- Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.)
- Experience in root cause analysis and corrective actions.
- Experience performing and/or approving process/equipment validations.
- Working knowledge of medical device regulations, both domestic and international
- Strong statistical and analytical skills
- Excellent communications skills, oral, written, electronic
- Will provide operations quality support for operations and production, including floor support
- Failure investigation (Root Cause Analysis and Corrective Action)
- Dispositioning non-conforming materials
- Approve process validations and equipment validations and Device Master Record changes
- Oversight of Non Conformance process and Stop Shipment
- Conduct risk analysis (Failure Mode Effects Analysis)
Surf Search focuses on executive search recruiting for health sciences and consumer products industries, including pharmaceutical, medical device, and biotech on a global basis. With over 35 years of combined experience in executive recruiting, our clients come to us to fill a wide range of key positions from high-level leadership positions to staff level roles.
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We only work with only a handful of clients at a time to fill key positions. We are thorough and -- we love what we do.
Role: Sustaining Engineer - Medical Devices
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