Lavori attuali relativi a R&D System Validation Principal Engineer - Medolla, Emilia-Romagna - BAXTER
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R&D System Validation Principal Engineer
2 mesi fa
Vantive is a new company built on our legacy, separating our ~$5B Kidney Care segment into a standalone entity. We're revolutionizing kidney care and other vital organ support, driven by a community of focused, courageous individuals who don't settle for mediocrity.
Job SummaryThe R&D System V&V Principal Engineer will play a key role in confirming compliance of medical equipment with regulations and specifications at the system level. You'll collaborate with multidisciplinary teams of engineers in a dynamic environment.
Key Responsibilities- Follow all phases of Verification and Validation at system and sub-system levels of medical products, from impact analysis to documentation preparation.
- Verify technical requirements, intended use, and user needs, as well as safety system compliance and risk control measures.
- Develop tools, test benches, and test methods to support test activities, and participate in cross-functional and cross-site teams.
- Support internal and external audits, manage instruments and tools, and collaborate on investigation, feasibility, and root cause analysis.
- Master's Degree in Electronic Engineering or Biomedical Engineering.
- ISTQB certificate preferred, with 5+ years of experience in R&D, System VV, and medical device products.
- Understanding of medical device product design and regulatory processes, as well as knowledge of applicable standards and regulations (FDA, ISO, and IEC).
- Deep knowledge of Design Control and Design of Experiments, with familiarity with Electronic and Software instruments and tools used in VV labs.
- Experience with LabView and Test Stand development preferred, with ability to communicate effectively in an international and multi-site environment.
