V&V Leader

2 mesi fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Vantive: A New Company Built On Our Legacy

Baxter 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.

Summary

We are seeking an exceptional individual to lead the verification and validation activities of our innovative electromechanical medical product. As the V&V leader, you will play a crucial role in ensuring the flawless performance and regulatory compliance of our products.

Key Responsibilities

  • Coordinate Sys V&V team as technical leader
  • Verify technical requirements
  • Validate intended use and user needs
  • Safety system verification and compliance to
  • Risk Control Measures Verification
  • Labeling and Training material Verification
  • Develop tool/test bench/test method for supporting test activities
  • Collaborate on investigation, feasibility and root cause analysis
  • Active participation in multi-functional and/or cross-sites teams
  • Support on internal and external Audit
  • 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
  • Familiarity with Electronic and Software instruments and tools used in V&V lab
  • Familiarity with Statistical Analysis and Test Methods Validation
  • Familiarity with system design, electronics, mechanical and software integration
  • Experience with LabView and Test Stand development is preferred
  • Able to communicate optimally, both verbally and in writing, within an international and multi-site environment
  • Team working approach, Problem-solving attitude and ability to organize and prioritize tasks

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