R&D System V&V Principal Engineer Modena

R&D System V&V Principal Engineer
Modena
Emilia Romagna, Modena

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. 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 is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Summary The R&D System V&V Principal Engineer will play a key role in the confirmation by examining and providing objective evidence that the medical equipment (i. e. Dialysis machine) is complying with regulations and specifications at the 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 the 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 Accommodation Vantive 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. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive 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. J-18808-Ljbffr