DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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Title: Verification & Validation Engineer (V&V Engineer)
Location: On-site at Plymouth, MN
Duration: 12 Months
Description:
As a member of the Client 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.
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 the 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, and 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 the results in testing platforms like ALM.
Collaborate with the 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 the 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
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.