Hardware Test Engineer; Medical Device

Position: Hardware Test Engineer (Medical Device)
Job Title:

Hardware Test Engineer - Verification & Validation

Job Description

As a Hardware Test Engineer on the Verification and Validation engineering team, you will support 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.

In this role, you will collaborate closely with cross‑functional partners in research and development, project management, quality, and manufacturing to ensure safe, reliable, and high‑quality products.

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.

+ Design hardware and/or software tools and fixtures needed to execute test methods efficiently and to analyze test data effectively.

+ Review, understand, and characterize electrical and mechanical designs to develop robust test methods and ensure complete requirements coverage.

+ 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 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…