Test Engineer

EPM Scientific; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading medical device firm is seeking a Contract Test Engineer in Boston, Massachusetts. The ideal candidate will have over 5 years of experience in test engineering specifically for electro-mechanical medical devices, alongside a robust background in V&V testing. Responsibilities include developing and executing test protocols, conducting various tests, and ensuring compliance with FDA and ISO standards. Strong analytical and communication skills are essential for success in this role.

Qualifications

• 5+ years of experience in test engineering for electro-mechanical medical devices.
• Strong background in V&V testing, including protocol writing and execution.
• Hands-on experience with sensors and actuators.

Responsibilities

• Develop, execute, and document V&V test protocols.
• Design and set up test fixtures and equipment.
• Conduct reliability and environmental testing.

Skills

V&V testing

Test engineering

Hands-on hardware evaluation

Problem-solving

Communication skills

Tools

Oscilloscopes

Data acquisition systems

Force meters

Multimeters

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.