Hardware Test Engineer

Job Description

Join our team as a Hardware Test Engineer. In this role, you will support product verification, validation, and compliance test activities for electrical and mechanical medical device components and systems. Your expertise will be critical throughout all levels of product development, from prototype components to final system design. You will plan, develop, execute, and validate test methods, while creating the associated documentation. Additionally, you will interface with and support various groups, including R&D, Project Management, Quality, and Manufacturing.

Responsibilities

• Develop and execute verification test methods, protocols, and reports for verifying requirements on components and systems.
• Drive quality into product development through analysis, testing, and providing timely feedback of test results to the cross-functional team.
• Reverse engineer designs, review requirements, and fully understand design features to perform test impact assessments, create test strategy, and develop full test plans.
• Design test cases that include methodology, test setups, materials, equipment, procedures, and acceptance criteria based on requirements and standards.
• Perform functional testing of mechanical assemblies, electrical circuits, and systems.
• Serve as a key contributor to cross-functional team meetings and design reviews.
• Review and analyze requirements and compliance standards as part of test development.
• Support the hardware team in product development, concept feasibility, pre-compliance, and change activities by developing tests, collecting, and providing test data.
• Design hardware and/or software tools and fixtures used to execute test methods and analyze data.
• Review, understand, and characterize electrical/mechanical designs to develop test methods and ensure coverage of requirements.
• Lead small teams through test projects for electromechanical components and systems.
• Read and understand medical compliance standards and requirements, evaluate risk, and develop test procedures that ensure requirements are met.
• Lead test execution, including being onsite at third-party medical device safety test labs.

Essential Skills

• 1+ years experience with electromechanical systems.
• 1+ years experience performing functional testing of hardware systems.
• 1+ year experience in a regulated setting (Medical/Automotive/Defense).
• Experience developing test procedures from requirements.
• Bachelor’s degree in Electrical, Computer, or Biomedical Engineering.
• Experience using electrical/mechanical lab equipment such as oscilloscopes, DMMs, power supplies, force/pressure gauges, calipers, thermometers, flow meters, and scales.

Additional Skills & Qualifications

• Bachelor’s degree in engineering with 3+ years of experience or a Master’s degree with 2+ years of experience in test engineering.
• Experience with system and component level V&V testing, including plans, procedures, reports, equipment, and test methods.

Work Environment

This role will be based in an office setting, working primarily within a lab environment. You will operate large pieces of capital equipment as an end user would, and conduct system testing following software updates. The position requires working hands-on in the lab to ensure the effectiveness of the testing processes.