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Validation engineer • minneapolis mn
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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
Use own expertise / guidance from others to identify / resolve critical issues.
Understanding / application of root cause analysis methods.