Validation Engineer

Precision Edge Surgical Products Company LLC

Angola, IN, United States
Not specified
Bs in mechanical or bio-medical engineering
Experience in medical device manufacturing
Blueprint and engineering schematic reading
Precision Edge Surgical Products Company LLC is seeking a Validation Engineer to support operations in Indiana and Michigan. The ideal candidate should have a background in Mechanical or Bio-Medical Engineering, with experience in medical device manufacturing and strong analytical skills

Job Summary

  • The role involves conducting validation activities in compliance with Regulatory standards and Precision Edge Surgical procedures.
  • Candidates will develop and execute validation documentation including equipment IQ/OQ, process OQ, and process PQ.
  • The position requires working as part of a multi-site team supporting locations in Indiana and Michigan.

Matching Summary

Match Score: 85

Precision Edge Surgical Products Company LLC is seeking a Validation Engineer to support operations in Indiana and Michigan. The ideal candidate should have a background in Mechanical or Bio-Medical Engineering, with experience in medical device manufacturing and strong analytical skills.

Skills & Requirements

Must-have

  • BS in Mechanical or Bio-Medical Engineering
  • Experience in Medical Device manufacturing
  • Blueprint and engineering schematic reading
  • Execute validation protocols IQ OQ PQ
  • Develop validation documentation plans

Nice-to-have

  • Experience in CNC machining processes
  • Six Sigma Lean manufacturing knowledge
  • Process capability and statistics experience
  • High volume-manufacturing environment experience
  • Ability to lift 50 pounds

Key Requirements

  • BS in Mechanical or Bio-Medical Engineering
  • Medical Device experience preferred
  • Contract manufacturing background desirable

Work Rights

Not specified

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