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Senior Manufacturing Engineer

5 months ago

Santa Rosa, United States Meet Full time

Meet has recently partnered up with a medical device company in Santa Rosa, CA developing innovative therapies for the interventional treatment of vascular disease with the first of its kind, class III cardiovascular implant. The client is looking for a seasoned manufacturing engineer to join their NPI team. This is a fully onsite role with relocation available for qualified candidates.

Responsibilities

  • Design and develop manufacturing processes for new products and/or changes to existing products
  • Design and develop fixtures and tooling for the manufacturing process
  • Develop and execute process validation protocols (IQ/OQ/PQ)
  • Support production line transfer
  • Perform Installation Qualification (IQ) equipment protocols and reports
  • Support manufacturing and quality with addressing NCMR issues
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
  • Identifies hazards and mitigates risks associated with identified hazards in Process FMEA.

Qualifications

  • Bachelor's Degree in Mechanical Engineering (or related field)
  • 5+ years of manufacturing engineering experience REQUIRED - (medical device development experience highly preferred)
  • Proven expertise in supporting manufacturing line transfer, executing process validation protocols (IQ/OQ/PQ), and risk assessment.
  • Applicable knowledge of Minitab, JMP, or other statistic tools
  • Experience in Nitinol-based devices, Class II, Class III and/or active implants is highly preferred.