V&V Leader

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. 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. Summary You'll play the role of System V&V leader, when needed, following all phases of Verification and Validation at system and sub-system level of an electromechanical 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. What you'll be doing The V&V activities include: Coordination of Sys V&V team as technical leader 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 Familiarity with Electronic and Software instruments and tools used in V&V lab Familiarity with Statistical Analysis and Test Methods Validation Familiarity 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 Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. 132147