Test Engineer

The Test Engineer is responsible for planning, developing, and executing verification activities for medical device products and systems throughout the Product Development Process (PDP). This role ensures products meet System and Design Requirements, comply with design controls, and are thoroughly verified before release. The Test Engineer collaborates closely with Systems Engineers, Physicists, and Development Engineers to support product development, design verification, and manufacturing transition activities. Key Areas of Responsibility Evaluate System and Design Requirements to define verification strategies, test cases, and performance criteria. Develop verification plans, including resource, equipment, unit-under-test (UUT), and external testing requirements. Create, execute, and maintain verification protocols and regression test libraries. Analyze test results, document findings, and prepare verification reports and test summary documentation. Verify compliance with System and Design Requirements prior to design freeze. Support system integration, product development, and manufacturing transfer activities. Develop Production Equivalence Assessments to ensure verification devices are production representative. Coordinate test planning inputs from Systems Engineers, Physicists, and other subject matter experts. Investigate returned products, collect and analyze data, and identify trends or performance issues. Provide technical expertise and support for verified products and systems. Delegate and monitor testing activities as needed.