Vantive: A New Company Built On Our LegacyBaxter 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.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.SummaryThe 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 doingYou'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 requirementsValidation of intended use and user needsSafety system verification and compliance to 60601-2-16Risk Control Measures verificationLabeling and Training material verificationDevelopment of tool/test bench/test method for supporting test activitiesCollaboration on investigation, feasibility and root cause analysisActive participation in cross-functional and/or cross-sites teamsSupport on internal and external AuditManagement of instruments/toolsWhat you'll bringMaster's Degree in Electronic Engineering or Biomedical EngineeringISTQB certificate is preferred5+ years of experience working in R&D, in System V&V and experience with medical device products is preferredUnderstanding of medical device product design and regulatory processesKnowledge of applicable standards and regulations (FDA, ISO and IEC)Deep knowledge of Design Control and of Design Of ExperimentsFamiliar with Electronic and Software instruments and tools used in V&V labFamiliar with Statistical Analysis and Test Methods ValidationFamiliar with system design, electronics, mechanical and software integrationExperience with LabView and Test Stand development is preferredAble to communicate effectively, both verbally and in writing, within an international and multi-site environmentTeamworking approach, Problem-solving attitude and ability to organize and prioritize tasks
