Electromechanical Medical Product V&V Specialist

1 settimana fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

At Baxter, we are revolutionizing kidney care and other vital organ support. We are seeking a highly skilled Electromechanical Medical Product V&V Specialist to join our world-class R&D organization. As a V&V leader, you will play a crucial role in ensuring the flawless performance and regulatory compliance of our products.

About the Role

The V&V activities include:

  • Coordination of Sys V&V team as technical leader
  • 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 multi-functional and/or cross-sites teams
  • Support on internal and external Audit
  • Management of 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

Baxter is committed to ensuring the safety and quality of our products. Our team of experts is dedicated to delivering innovative solutions that meet the highest regulatory standards.

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