Test Engineer

Summary
You would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Interface with/support different groups, e.g., R&D, Project Management, Quality, and manufacturing.

Responsibilities

• Under supervision, Develop/execute verification test methods, protocols, and reports for verification of requirements on components and systems
• Drive quality into product development through analysis, test, and timely feedback of test results back to team
• Under supervision, Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria based on requirement and standard
• Execute functional testing of mechanical assemblies, electrical circuits, and systems
• Support hardware team in product development, concept feasibility, pre compliance and change activities by developing test, collecting, and providing test data
• Under supervision, 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
• Read/understand medical compliance standards and requirements, evaluate risk, and develop test procedures to ensure requirements are met
• Perform hands on test execution in the lab and at third party medical device test labs, communicate all defects/issues/failures during the test execution.
• Under supervision, develop and implement feasibility and characterization testing on designs
• Analyze test data for conformance to pre-determined acceptance criteria and record clearly results in testing platforms like ALM.
• Collaborate with System team to better understand requirements and improve test effectiveness.
• Actively participate in improving existing testing scenarios and test cases.
• Maintain laboratory equipment and inventory levels for laboratory supplies
• Perform troubleshooting, hands on rework and calibration of electromechanical Systems

Qualifications

• Bachelor’s degree in Engineering with 1+ years of experience
• Experience with system and component level electromechanical V&V testing, plans/procedures/reports, equipment, and test methods preferred
• Demonstrated results in both Troubleshooting/resourcefulness; use own expertise/guidance from others to identify/resolve critical issues. Understanding/application of root cause analysis methods.
• Knowledge of electrical/mechanical engineering disciplines with ability to read, understand and analyze electrical schematics/ mechanical drawings
• Experience using electrical/mechanical lab equipment. e.g., oscilloscope, DMM, power supply, force/pressure gauge, caliper, thermometer, flow meter and scales
• Takes a hands-on approach to testing, fault diagnosis and isolation
• Experience creating detailed, clear, and complete documentation and records
• Demonstrated experience collaboratively and effectively across disciplines/project teams
• Comfortable/effective in a fast-paced environment, where small teams share a broad variety of duties

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