Validation Engineer

Precision Edge Surgical Products Company LLC

Not specified
Bs in mechanical or bio-medical engineering
Conduct validation activities per regulatory standards
Develop and execute iq/oq/pq protocols
Precision Edge Surgical Products Company LLC is seeking a Validation Engineer with 3-5 years of experience in mechanical or biomedical engineering, ideally in medical device manufacturing. The role involves conducting validation activities, ensuring compliance with quality and safety standards, and participating in a collaborative, multi-site team environment

Job Summary

  • The role involves conducting validation activities in compliance with regulatory standards and company procedures for medical devices.
  • Candidates must develop validation documentation including plans, protocols, and reports while executing equipment and process qualification.
  • The position requires a candidate with a BS in Mechanical or Bio-Medical Engineering and 3-5 years of relevant experience.

Matching Summary

Match Score: 85

Precision Edge Surgical Products Company LLC is seeking a Validation Engineer with 3-5 years of experience in mechanical or biomedical engineering, ideally in medical device manufacturing. The role involves conducting validation activities, ensuring compliance with quality and safety standards, and participating in a collaborative, multi-site team environment.

Skills & Requirements

Must-have

  • BS in Mechanical or Bio-Medical Engineering
  • Conduct validation activities per regulatory standards
  • Develop and execute IQ/OQ/PQ protocols
  • Blueprint and engineering schematic interpretation
  • Experience with medical device manufacturing

Nice-to-have

  • Six Sigma and Lean manufacturing experience
  • CNC machining process knowledge
  • Process capability and statistics expertise
  • Ability to lift 50 pounds
  • Multi-site team collaboration

Key Requirements

  • BS in Mechanical or Bio-Medical Engineering
  • 3 to 5 years of experience
  • Medical device manufacturing experience preferred
  • FLSA Status: Salary Exempt

Work Rights

Not specified

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