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MUST HAVES:

- Has experience in the medical sector  

- Previous engineer experience is required

- Electrical engineering degree or similar only relevant to this specific Position

- Demonstrated experience in system V&V testing  

- Experience testing in an FDA regulated environment        

- Tools Used: Polarion- Azure-Devops (nice to have)

Job Responsibilities:

Perform Verification of Class II Medical Device Kidney Dialysis medical device.

Test embedded application and software in compliance with 21 CFR 820.70 (i) and 21 CFR 820.30- including validation strategy documents- software requirement specifications- validation protocols and reports- and operating procedures.    

Develop the Validation Protocols (manual) for the function testing of Renal Medical Device.    

Develop system- integration and regression level test scenarios.    

Develop verification plan- test summary report in Polarion.    

Work with cross functional team on preparing for formal test execution    

Participate in Agile/ Scrum development environment.    

Develop system- integration and regression level test scenarios for new development for human factor studies.