Hardware Test Engineer

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.
• 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.

Requirements

• 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.
• Experience working with design verification and validation for medical devices or other regulated electromechanical systems.
• 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 participating in and contributing to cross-functional design reviews.
• Detail-oriented approach to documentation, ensuring test methods, results, and reports are complete, accurate, and traceable.
• Interest in long-term project work, with the ability to support multi-year verification and validation efforts.

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 participating in and contributing to cross-functional design reviews.
• Detail-oriented approach to documentation, ensuring test methods, results, and reports are complete, accurate, and traceable.
• Interest in long-term project work, with the ability to support multi-year verification and validation efforts.