About this opportunity
EPM Scientific lists this Test Engineer opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Overview
We are looking for a highly skilled Contract Test Engineer with deep experience in electro‑mechanical medical devices, including V&V (Verification & Validation), automated and manual test development, and hands‑on hardware evaluation. The ideal candidate has a strong understanding of testing methodologies used in regulated medical device environments (ISO 13485, FDA 21 CFR 820).
Responsibilities
Develop, execute, and document Verification & Validation (V&V) test protocols for electro‑mechanical medical devices.
Design and set up test fixtures, equipment, and instrumentation.
Conduct reliability testing, environmental testing, stress testing, and functional testing.
Analyse test data, identify root causes, and provide clear recommendations to engineering teams.
Collaborate with design engineers to review requirements and ensure test coverage.
Maintain documentation according to FDA and ISO 13485 standards, including test reports, deviation reports, and risk documentation.
Support troubleshooting and failure analysis activities.
Ensure compliance with Design Controls throughout the testing lifecycle.
Contribute to continuous improvement of test processes and tools.
Required Experience & Skills
5+ years of experience in test engineering for electro‑mechanical medical devices (must‑have).
Strong background in V&V testing, including protocol writing, execution, and reporting.
Hands‑on experience with sensors, actuators, motors, PCBs, firmware‑driven systems, and mechanical subsystems.
Knowledge of IEC 60601, safety testing, and general medical device standards.
Experience in regulated medical device environments (FDA, ISO 13485, Design Controls).
Proficiency in using test equipment: oscilloscopes, data acquisition systems, force meters, signal generators, multimeters, etc.
Ability to read and interpret engineering drawings, schematics, and requirements.
Strong analytical, documentation, and problem‑solving skills.
Excellent communication skills and ability to work cross‑functionally.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.