Principal Test Engineer

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies.

Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role

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 test expertise will be applied to all levels of product development from prototypes components to final system design. This will include planning developing, executing, and validating test methods/creating associated documentation.

Interface with/support different groups, e.g., R&D, Project Management, Quality, and manufacturing.

What you'll be doing

• Lead the development of complete electromechanical test solutions including strategies, plans, methods, protocols, and reports for verification of requirements on components and systems.
• Lead medium to large teams through the planning and execution of Test Engineering programs. This includes constructing detailed, accurate project schedules, interfacing with project management, design, quality, regulatory, compliance and other R&D groups.
• Drive quality into product development through analysis, test, and timely feedback of test results/conclusions/influence to the cross functional teams
• Reverse engineer designs, review/analyze requirements and fully understand design features to perform test impact assessments and define the scope of test work
• Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria based on requirements and standards
• Guide teams in the functional testing of mechanical assemblies, electrical circuits, and systems
• Engaged point of contact for test to cross-functional team meetings/design reviews
• Support hardware and software teams in product development, concept feasibility, pre-compliance, integration and change activities by developing test, collecting, and presenting test data
• Lead the design/qualification of hardware and software tools/fixtures used to execute test methods and analyze data
• Review, understand and characterize electrical/mechanical designs to lead the develop of test methods and ensure coverage of requirements
• Lead medium to large teams through test projects for electromechanical components and systems
• Read/understand medical compliance standards and requirements, evaluate risk, and develop test procedures the ensure requirements are met
• Lead test execution at third party medical device safety test labs
• Using engineering principles and best practices develop and implement feasibility and characterization testing on design concepts and prototypes

What you'll bring

• Bachelor's or master's degree in engineering. 8+ years of experience in test engineering
• Experience with medical device systems and component level V&V testing, plans/procedures/reports, equipment, and test methods
• 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…