R&D System V&V Principal Engineer

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Summary

The R&D System V&V Principal Engineer will play a key role in the confirmation by examination and provision of objective evidence that the medical equipment (i.e. Dialysis machine) is complying with regulations and specification at system level. You will collaborate with multidisciplinary teams of engineers and work in a dynamic environment.

What you'll be doing

You'll follow all the phases of Verification and Validation at system and sub-system level of a medical product, from the impact analysis, through the definition of the test activities up to the preparation of all the documentation in line with the regulatory/standard requests and the QMS.

The V&V activities include:

• Verification of technical requirements
• Validation of intended use and user needs
• Safety system verification and compliance to 60601-2-16
• Risk Control Measures verification
• Labeling and Training material verification
• Development of tool/test bench/test method for supporting test activities
• Collaboration on investigation, feasibility and root cause analysis
• Active participation in cross-functional and/or cross-sites teams
• Support on internal and external Audit
• Management of instruments/tools

What you'll bring

• Master's Degree in Electronic Engineering or Biomedical Engineering
• ISTQB certificate is preferred
• 5+ years of experience working in R&D, in System V&V and experience with medical device products is preferred
• Understanding of medical device product design and regulatory processes
• Knowledge of applicable standards and regulations (FDA, ISO and IEC)
• Deep knowledge of Design Control and of Design Of Experiments
• Familiar with Electronic and Software instruments and tools used in V&V lab
• Familiar with Statistical Analysis and Test Methods Validation
• Familiar with system design, electronics, mechanical and software integration
• Experience with LabView and Test Stand development is preferred
• Able to communicate effectively, both verbally and in writing, within an international and multi-site environment
• Teamworking approach, Problem-solving attitude and ability to organize and prioritize tasks