Stefanini
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Details:
Stefanini Group is hiring!
Stefanini is looking for Test Engineer in Plymouth, MN (Onsite)
For quick Apply, please reach out to Sangeeta Dasadhikary – call: 248-582-6547/ email: [email protected]
Description:
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
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