Medical Device Validation Engineer

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