EU MDR Manufacturing Engineer

Cynet Systems   •  

Westford, MA

Industry: Technology

  •  

5 - 7 years

Posted 125 days ago

  by    Cynet EngineeringTeam

This job is no longer available.

We are looking for EU MDR - Manufacturing Engineer for our client in Plymouth, MN / Pleasanton, CA / WestFord, MA

Job Title: EU MDR - Manufacturing Engineer

Job Location: Plymouth, MN / Pleasanton, CA / WestFord, MA

Job Type: Contract 12 Months

"US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time."

Job Description:

  • 5 to 6 years of Process Validation (IQ, OQ & PQ) and test method validation experience, especially cardiovascular products or any electro-mechanical products
  • Experience in process characterization, Gage R&R studies.
  • Knowledge in Statistical data analysis & Minitab.
  • Experience in working with Medical devices manufacturing – ISO 13485, 21 CFR 820 & Med dev.
  • Knowledge in Risk Management per ISO 14971 – PFMEA.
  • Knowledge in the change control process in PMS systems
  • Creation of Routers & BOM in SAP
  • Knowledge in fixture design.
  • xperience in process characterization, Gage R&R studies.
  • Knowledge in Statistical data analysis & Minitab.
  • Experience in working with Medical devices manufacturing – ISO 13485, 21 CFR 820 & Med dev.
  • Knowledge in Risk Management per ISO 14971 – PFMEA.
  • Knowledge in the change control process in PMS systems
  • Creation of Routers & BOM in SAP
  • Knowledge in fixture design.