Senior Test & Validation Engineer - Medical Devices

TechDigital Group; Marlborough (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A technology solutions provider is seeking an experienced Validation Engineer to lead test method validation and Verification and Validation processes for disposable medical devices in Marlborough. The ideal candidate will have over 7 years of related experience, expertise in relevant regulations, and strong organizational skills. This is a full-time onsite position offering a dynamic work environment.

Qualifications

• 7+ years of experience in Verification and Validation of processes.
• Knowledge of relevant regulations (ISO13485, FDA 21 CFR Part 820).
• Experience in defining and managing Verification and Validation plans.

Responsibilities

• Define test requirements and plan for design verification.
• Write test protocols and execute tests, analyzing results.
• Lead investigations on test failures and develop guidelines.

Skills

Test method validation

Verification and Validation

Data analysis

Education

Master's degree or equivalent experience in related engineering or scientific fields

Tools

DOE, OQ, Gage R&R

Injection molding

Mechanical testing methods

Job description

A technology solutions provider is seeking an experienced Validation Engineer to lead test method validation and Verification and Validation processes for disposable medical devices in Marlborough. The ideal candidate will have over 7 years of related experience, expertise in relevant regulations, and strong organizational skills. This is a full-time onsite position offering a dynamic work environment.