R&D System Verification and Validation Principal Engineer

4 giorni fa

Modena, Emilia-Romagna, Italia Baxter International A tempo pieno
About Vantive

Vantive is a new company built on Baxter's legacy in acute therapies and home and in-center dialysis. We provide best-in-class care to people worldwide, driven by a focus on innovation and a commitment to improving patients' lives.

Job Summary

The R&D System V&V Principal Engineer will play a key role in confirming that medical equipment, such as dialysis machines, complies with regulations and specifications at the system level. This role involves collaborating 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 and validate intended use and user needs.
  • Conduct safety system verification and compliance to 60601-2-16.
  • Develop tool/test bench/test method for supporting test activities.
  • Collaborate on investigation, feasibility, and root cause analysis.
  • Participate in cross-functional and/or cross-sites teams.
  • Support internal and external audits.
  • Manage instruments/tools.
Requirements
  • 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.
What We Offer

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please let us know.

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