Hardware Test Engineer

Hardware Test Engineer – Verification & Validation

This role is a hands-on hardware test engineering position focused on electrical and mechanical medical device components and systems. You will plan, develop, execute, and validate test methods from prototype components through final system design, ensuring products meet functional requirements and compliance standards in a regulated environment. The position offers the opportunity to design and run test procedures, work closely with cross-functional teams, and contribute directly to the quality and safety of complex electromechanical medical systems over a multi-year project.

Responsibilities:

• Develop and execute verification test methods, protocols, and reports to confirm requirements at both component and system levels.
• Drive product quality by analyzing test results and providing timely, data-driven feedback to cross-functional teams.
• 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 that define 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 in a lab environment.
• Serve as a key contributor in cross-functional team meetings and design reviews, representing verification and validation perspectives.
• Review and analyze product requirements and compliance standards as part of test development activities.
• Support hardware product development, concept feasibility, pre-compliance, and change activities by developing tests, collecting data, and delivering clear test reports.
• Design hardware and software tools, fixtures, and test setups used to execute test methods and analyze resulting data.
• Review, understand, and characterize electrical and mechanical designs to develop robust test methods that ensure complete requirements coverage.
• Lead small teams through test projects for electromechanical components and systems, coordinating test execution and documentation.
• Read and interpret medical compliance standards and requirements, evaluate associated risks, and develop test procedures that ensure full compliance.
• Plan and lead test execution activities, including onsite work at third-party medical device safety test laboratories when required.
• Run manual tests on large capital equipment and system-level hardware following software updates and design changes.
• Maintain accurate, organized test documentation, including test plans, procedures, records, and reports, in line with regulated environment expectations.

Essential

Skills:

• Minimum of 5+ years of experience working with electromechanical systems.
• At least 4+ years of experience performing functional testing of hardware systems.
• Minimum of 2+ years of experience working in a regulated environment such as medical, automotive, or defense.
• Experience developing test procedures directly from product requirements.
• Bachelor's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline.
• Bachelor's degree in engineering with at least 3+ years of test engineering experience, or a Master's degree in engineering with at least 2+ years of test engineering experience.
• Hands-on experience with system-level and component-level verification and validation testing, including creation of test plans, procedures, and reports.
• 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.
• Strong in test engineering for hardware, including test plan and test procedure development.
• Ability to perform functional testing and validation of complex electromechanical medical device components and systems.
• Experience working in an electronics or systems test lab environment.
• Ability to read, understand, and apply compliance standards, particularly in medical device or similarly regulated industries.
• Capability to lead small test project teams and coordinate verification activities.

Additional Skills &

Qualifications:

• Experience with design verification and validation for medical devices or other regulated electromechanical systems.
• Familiarity with Python or similar scripting languages for test automation, data collection, or analysis.
• Experience designing hardware and software tools, fixtures, and custom test setups to support verification activities.
• Strong analytical skills for reviewing requirements, assessing test impacts, and defining test strategies.
• Ability to reverse engineer designs to understand key features, interfaces, and potential failure modes.
• Comfort working with large capital equipment and complex system-level hardware.
• Effective communication skills for collaborating with R&D, project management, quality, and manufacturing teams.
• Experience…