Hardware Test Engineer

The Hardware Test Engineer will join the Validation engineering team and support product verification, validation, and compliance testing for electrical and mechanical medical device components and systems. You will contribute across the full product development lifecycle, from early prototypes to final system design, by planning, developing, executing, and validating test methods and creating associated documentation. In this role, you will collaborate closely with cross-functional teams, including R&D, Project Management, Quality, and Manufacturing, while developing test procedures and executing manual tests in a regulated environment., * Develop and execute verification test methods, protocols, and reports to verify requirements at both component and system levels.

• Drive quality into product development by performing analysis and testing, and by providing timely, data-driven feedback of test results 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, test setups, materials, equipment, procedures, and acceptance criteria based on requirements and applicable standards.
• Perform functional testing of mechanical assemblies, electrical circuits, and complete electromechanical systems.
• Serve as a key contributor in cross-functional team meetings and design reviews by presenting test strategies, results, and recommendations.
• Review and analyze product requirements and compliance standards as part of test development to ensure adequate coverage and traceability.
• Support the hardware team throughout product development, including concept feasibility, pre-compliance activities, and design changes, by developing tests and collecting and providing test data.
• Design hardware and software tools, fixtures, and test setups needed to execute test methods and to support data collection and analysis.
• Review, understand, and characterize electrical and mechanical designs to develop robust test methods that ensure full requirements coverage.
• Lead small teams through test projects for electromechanical components and systems, coordinating test planning, execution, and reporting.
• 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 being onsite at third-party medical device safety test laboratories as needed.
• Develop and maintain test plans, procedures, and associated documentation in alignment with regulatory and quality system requirements.
• Use test results to identify issues, support root cause analysis, and recommend design or process improvements., This position is based on-site in an office and laboratory setting. You will work hands-on with large pieces of capital equipment, operating the systems as an end user would to verify performance, particularly after software updates are implemented. The role involves regular use of electrical and mechanical lab equipment such as oscilloscopes, multimeters, power supplies, force and pressure gauges, calipers, thermometers, flow meters, and scales. You will work closely with engineering and cross-functional teams in a collaborative environment that emphasizes quality, regulatory compliance, and continuous improvement. The project is structured as a multi-year engagement with the potential to extend, offering the opportunity to see products evolve from prototype through final system verification in a professional lab environment.

Calipers Visionary Innovation Test Tools Electronics Prototyping Multimeters Test Design Coordinating Oscilloscope Communication Data Analysis Test Planning Code Coverage Systems Design Medical Devices Data Collection Test Engineering Analytical Skills Functional Design Mechanical Design Project Management Compliance Testing Functional Testing Root Cause Analysis Electrical Networks Design Verification Computer Engineering Pressure Measurement Product Requirements Laboratory Equipment Regulatory Compliance Procedure Development Test Execution Engine Electrical Engineering Biomedical Engineering New Product Development Quality Management Systems Engineering Design Process Verification And Validation Python (Programming Language) Continuous Improvement Process, * At least 4 years of experience working with electromechanical systems.

• At least 4 years of experience performing functional testing of hardware systems.
• At least 2 years of experience working in a regulated environment such as medical, automotive, or defense.
• Experience developing test procedures directly from requirements.
• Bachelors degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline.
• Minimum of 3 years of test engineering experience with a bachelors degree, or at least 2 years of test engineering experience with a masters degree.
• Hands-on experience with system- and component-level verification and validation testing, including creation and execution 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 test engineering skills, including test planning, test procedure development, and execution of hardware tests.
• Ability to perform functional testing of mechanical assemblies, electrical circuits, and integrated systems.
• Experience working in an electronics or systems test lab environment.
• Ability to interpret and apply compliance standards and requirements in test development.
• Strong analytical skills for reviewing requirements, assessing test coverage, and evaluating test results.
• Effective communication skills for collaborating with R&D, Project Management, Quality, and Manufacturing teams., * Experience with validation activities and design verification for complex electromechanical or medical device systems.
• Familiarity with Python for developing test tools, scripts, or data analysis utilities.
• Experience designing hardware and software tools and fixtures to support test execution and data collection.
• medical device, automotive, or defense industries with exposure to regulatory and compliance testing.
• Experience leading small teams through test projects, including planning, coordination, and reporting.
• Ability to reverse engineer designs and perform detailed test impact assessments when requirements or designs change.
• Comfort presenting test strategies, results, and recommendations in cross-functional design reviews.
• Strong documentation skills for creating clear, traceable, and compliant test plans, procedures, and reports., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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