R&D Therapy System Principal Engineer

col-wideJob Description: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.Job DescriptionSummaryThe R&D Therapy System Principal Engineer will execute system engineering tasks during the life cycle of an active medical device, from the design to development up to the sustaining.This person will collaborate with multidisciplinary teams and work in a global, dynamic, and fast-paced environment.What you'll be doingJoin Therapy Systems Engineering efforts for a complex, active medical deviceUnderstand human-factor engineering to translate user needs into system requirementsDevelop and maintain product requirements, design descriptions and other technical documentationCollaborate to maintain the product Design History File (DHF) of an active medical deviceCollaborate in Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.What you'll bringUniversity degree in Engineering or solid experience in relevant roles within medical device development (R&D)5+ years of working experience in product design, development, and/or testing in the area of medical deviceStrong understanding of System Design and Therapy developmentExperience with design for manufacturing and reliability is preferredAbility to communicate effectively within an international and multi-site environmentWelcome is experience related to regulations and standards (ISO 13485, IEC 62366, IEC 60601.1 IEC 60601.2.16, ISO 14971.21CFR801, MDD, MDR)Fluent knowledge of English both verbal and written