V&V Leader

3 settimane fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

About Baxter

Baxter is a leading medical products company that is on a journey to separate its ~$5B Kidney Care segment into a standalone company, Vantive. This new company will build on Baxter's nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to patients worldwide.

Our Mission

We are driven to improve patients' lives worldwide by revolutionizing kidney care and other vital organ support. Our team is focused, courageous, and committed to excellence in everything we do.

About the Role

We are seeking a highly skilled V&V Leader to join our world-class R&D organization at Baxter. As a V&V Leader, you will play a crucial role in ensuring the flawless performance and regulatory compliance of our electromechanical medical products. You will be responsible for leading verification and validation activities at the system and sub-system level, from impact analysis to test activities and documentation preparation.

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 regulatory standards
  • 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
  • Participate in multi-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
  • 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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