Process Validation Engineer

Job Description

Title:- Test Engineer

Duration:- 12+ Month

As a member of the client 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

• 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 dutiesCompany Description

Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.

Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities