Process Development Engineer - Medical Devices

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Location
Irvine, CA
Salary
$1 - $2
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Jul 05, 2018
Job ID
2608045
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Process Development Engineer - Medical Devices

Industry leading medical devices company seeks a Process Development Engineer to lead process development and scale up to production of a new Class III medical device.  This position would require up to 75% travel, primarily domestic.

Requirements for Process Development Engineer:
  • Bachelor's degree in engineering, ie. mechanical engineering, manufacturing engineering, or industrial engineering.  Advanced degree preferred
  • 5+ years experience in medical device manfuacturing
  • Experience developing medical device manufacturing processes, which includes working with design firms, suppliers, and contract manufacturing
  • A depth of experience in DFM - design for manufacturability, Lean Six Sigma, cGMP, supplier development
  • Strong process validation experience
  • The ability to travel up to 75%, primarily domestic
  • Excellent communications and technical skills

The Process Development Engineer will:
  • Develop and execute operations integration plan, facilitating supply chain strategy
  • Manage pilot production builds, lead operational transitions of all design transfer through development, clinical and commercialization.
  • Develop, manage and execute process validation plan
  • Through hands on engineering work, manage risk assessment and mitigations