Verification and Validation Engineer

Job Title : Verification and Validation Engineer

Location : Plymouth MN 55441

Duration : 12 months

As a member of the Acute Therapies Verification and Validation engineering team, 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 include but not limited to :

• 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

What you'll bring

• 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