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Medical Device Validation Engineer
Job in
Danvers, Essex County, Massachusetts, 01923, USA
Listed on 2026-05-07
Listing for:
REALIGN LLC
Full Time
position Listed on 2026-05-07
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Medical Device Validation Engineer
Location: Danvers, MA (Onsite)
Employment type: Fulltime
Responsibilities- 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.)
- Write clear TMV protocols and reports
- Create test procedures, acceptance criteria, and validation plans
- Interpret test methods, specifications, and engineering drawings
- 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
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