Test Method Validation Engineer (Class III medical device)

Job Title: Test Method Validation Engineer

Location: Acton, MA – 100% Onsite

Duration: 6 Months

Start Date: Mid-November 2026

Experience: 5–8 Years

We are seeking an experienced Metrologist / Test Method Validation Engineer to support a Class III medical device manufacturing environment.

Responsibilities:

• Develop, write, execute, troubleshoot, and report Test Method Validation protocols.
• Conduct root cause investigations for measurement issues and dimensional non-conformances (NCMRs).
• Support equipment validation, calibration investigations, and engineering/document change orders.
• Analyze validation data using Minitab and prepare technical reports.
• Review validation protocols and results with internal Quality teams and external suppliers.
• Support measurement system assessments and site-to-site correlation studies.

Required Qualifications:

• Bachelor’s degree in Engineering.
• 5–8 years of relevant metrology, test method validation, or medical device engineering experience.
• Class III medical device manufacturing experience.
• Hands-on experience with protocol writing, execution, troubleshooting, and reporting.
• Experience with NCMR investigations, root cause analysis, equipment validation, and change control.
• Proficiency in Minitab and strong analytical and problem-solving skills.
• Ability to work onsite in Acton, MA, five days per week.

Preferred: Vision-system experience and calibration out-of-tolerance (OOT) investigations.