Hardware Test Engineer (Medical Device)

About the role

A Hardware Test Engineer on the Verification and Validation engineering team supports product verification, validation, and compliance testing for complex electrical and mechanical medical device components and systems. You will contribute across the full product development lifecycle, from early prototype components to final system design, by planning, developing, executing, and validating test methods and creating clear, compliant documentation.

Responsibilities

• Develop and execute verification test methods, protocols, and reports to verify requirements at both component and system levels.
• Drive quality into product development through thorough analysis, testing, and timely communication of test results to the cross-functional team.
• Reverse engineer designs, review requirements, and fully understand design features to perform test impact assessments and create comprehensive test strategies and plans.
• Design detailed test cases, including methodology, setups, materials, equipment, procedures, and acceptance criteria based on requirements and applicable standards.
• Perform functional testing of mechanical assemblies, electrical circuits, and integrated systems.
• Serve as a key contributor in cross-functional team meetings and design reviews, providing test and quality insights.
• Review and analyze product requirements and compliance standards as part of test development to ensure full coverage and traceability.
• Support the hardware team in product development, concept feasibility, pre-compliance activities, and change initiatives by developing tests, collecting data, and providing clear test results.
• Lead small teams through test projects for electromechanical components and systems, coordinating activities and ensuring timely completion of test deliverables.
• Read and interpret medical compliance standards and requirements, evaluate associated risks, and develop test procedures that ensure compliance.
• Plan and lead test execution activities, including onsite testing at third-party medical device safety test laboratories.
• Develop test procedures from product and system requirements and execute manual tests on hardware systems.
• Use appropriate test equipment and lab tools to set up, run, and document verification and validation tests.
• Provide clear, structured test documentation, including plans, procedures, data records, and final reports.

Essential Skills

• At least 2 years of experience working with electromechanical systems.
• At least 2 years of experience performing functional testing of hardware systems.
• At least 1 year of experience working in a regulated environment such as medical, automotive, or defense.
• Experience developing test procedures directly from product and system requirements.
• Bachelor’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline.
• 2+ years of experience in test engineering with a bachelor’s degree, or 1+ years of experience in test engineering with a master’s degree.
• Hands-on experience with system-level and component-level verification and validation testing, including creation of test plans, procedures, reports, and use of appropriate test methods and equipment.
• Proficiency using electrical and mechanical lab equipment such as oscilloscopes, digital multimeters (DMM), power supplies, force and pressure gauges, calipers, thermometers, flow meters, and scales.
• Practical experience in test engineering and test equipment operation within an electronics or systems test lab environment.
• Ability to perform functional testing on mechanical assemblies, electrical circuits, and integrated systems.
• Experience with test procedure development, hardware testing, and design verification in an engineering context.

Additional Skills & Qualifications

• Experience with test engineering in an electronics lab or systems test environment.
• Familiarity with automating test tools, scripts, or data analysis.
• Experience with validation activities and design verification for electromechanical products.
• Experience designing and implementing test tools, fixtures, and simple hardware or software utilities to support test execution and data analysis.
• Strong analytical skills to review and interpret requirements, standards, and design documentation.
• Experience working with cross-functional teams including R&D, project management, quality, and manufacturing.
• Ability to lead small test teams and coordinate test activities across multiple stakeholders.
• Comfort working with medical device compliance standards and safety testing processes.
• Strong written communication skills for creating clear test methods, procedures, and reports.
• Detail-oriented mindset with a focus on risk evaluation, requirement coverage, and traceability.