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Medical Device Validation Engineer

AceStack LLC

Job Title : Medical Device Validation Engineer Location : Danvers, MA (Onsite) Fulltime Must Have Technical/Functional Skill

  • Prepare TMV protocols and reports and perform Validation
  • Apply Gage R&R (repeatability & reproducibility)
  • Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)
Roles & Responsibilities
  • Write clear TMV protocols and reports
  • Create test procedures, acceptance criteria, and validation plans
  • Interpret test methods, specifications, and engineering drawings
  • Apply Gage R&R (repeatability & reproducibility)
  • Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)
  • Collaborate with Engineering, Quality, Operations, and R&D
  • Produce clear, audit ready documentation to meet ISO and regulatory requirements for medical devices.
  • Train operators, engineers, and quality staff on validated inspection methods and best practice AceStack LLC

Vacancy posted 5 days ago
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