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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
Vacancy posted 2 days ago
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