Verification & Validation Engineer

Stefanini Group•Plymouth, MN

19h•Onsite

About The Position

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.

Requirements

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

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.