Senior Manufacturing Process Engineer

21 hours ago


San Diego, California, United States Meet Recruitment Full time

Job Summary

Meet Recruitment is seeking a highly skilled Senior Manufacturing Process Engineer to join our team. As a key member of our process development and manufacturing engineering department, you will be responsible for developing new and improved manufacturing processes for catheter-based medical devices and manufacturing scale-up projects for existing product lines.

Key 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, 5-10 years of experience preferred.
  • Previous catheter process development and manufacturing experience is required.
  • Experience in Design for Manufacturing, Assembly, and Test (DFMAT), Six Sigma, Lean Manufacturing & Design of Experiments (DoE).
  • 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.


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