Medical Device Validation Engineer-1

Job Type: Full Time

Job Category: IT

Job Description

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

Required Skills

DevOps Engineer

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