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.

Knowledge, Skills & Abilities

• Bachelor's degree in Engineering, Physics, or a related technical field.
• 5+ years of verification, validation, or test engineering experience in a regulated industry.
• Strong understanding of design controls, verification processes, and product development requirements.
• Experience developing design control documentation, including Requirements Traceability Matrices (RTMs), V&V Plans, verification protocols, and verification reports.
• Experience analyzing System Requirements and Design Specifications.
• Proficiency with requirements management tools (Jama preferred).
• Understanding of Product Development Process (PDP) phases and deliverables.
• Knowledge of ISO 14971 risk management and safety risk analysis.
• Experience with environmental, shipping, EMC, and safety testing (IEC 60601-1, IEC 60601-1-2, IEC 61010, IEC 61326).
• Experience with test automation and automation tools.
• Familiarity with Windchill, JIRA, Confluence, or similar document and issue management systems.
• Experience using verification equipment such as oscilloscopes, DMMs, environmental chambers, force gauges, and specialized medical device test equipment.
• Experience with AI tools such as Claude or similar platforms.
• Strong technical writing and documentation skills.