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Manufacturing Engineer

4 months ago

Irvine, United States People With Chemistry Full time
Senior Manufacturing Engineer (Onsite)

A growing electrosurgical medical device company located in Orange County is looking to hire a Senior Engineer for their manufacturing engineering department. The company is developing electromechanical devices for Orthopedic, Neuro, Spine, and Dental Surgery. This role will lead and execute manufacturing projects to support new product introduction, process development and optimization, and manufacturing scale-up efforts.

Role Responsibilities:
  • Create and implement new manufacturing processes for new and current medical devices.
  • Work with suppliers around the world to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are being delivered.
  • Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • Create manufacturing documentation including but not limited to work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
  • Lead team of engineers and technicians on business activities for manufacturing.
  • Innovate, design, and develop processes, procedures, tooling and/or automation.
Qualification Requirements:
  • Bachelor's Degree in Engineering (Mechanical, Electrical, or similar)
  • Minimum of 4 years experience as a process/manufacturing engineer in the medical device industry, 6-7 years of experience preferred.
  • Electromechanical/Electronics medical device manufacturing experience and knowledge of IEC 60601-x, ISO 13485.
  • CNC Manufacturing Experience
  • FMEA, root cause analysis, GD&T
  • Experience creating technical manufacturing documentation such as work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
  • Understanding of medical device Quality Management Systems, design controls, and product development processes.
  • SolidWorks/CAD software experience.