Validation Engineer

Details:

Job Description

Stefanini Group is hiring!

Stefanini is looking for Validation Engineer in Plymouth, MN

For quick Apply, please reach out to Sangeeta Dasadhikary- call: 2485826547 / email: Sangeeta.Dasadhikary@stefanini.com

Work Hours: M-F (40 hours)

Work Location: Plymouth, MN

Shift: 1st Shift

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.

• 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.
  
  

Job Requirements

Details:

• 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.
  
  

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.