This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. 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 Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to ****** 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 . 120041
