Test Engineer

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).

📍 Location: Boston- USA
📅 Employment Type: Contract
🚀 Start: ASAP

Key Responsibilities

• Develop, execute, and document Verification & Validation (V&V) test protocols for electro‑mechanical medical devices.
• Perform testing on mechanical, electronic, firmware‑driven, and system‑level components.
• 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.