Sustaining Engineer - Medical Devices

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Irvine, CA
Job Type
Direct Hire
Feb 05, 2018
Job ID
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

Job Function:
  • 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)