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R&D Therapy System Principal Engineer

2 mesi fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

About Vantive

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.

Our Mission

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Job Description

Summary

The R&D Therapy System Principal Engineer will execute system engineering tasks during the life cycle of an active medical device, from the design to development up to the sustaining.

This person will collaborate with multidisciplinary teams and work in a global, dynamic, and fast-paced environment.

Key Responsibilities

  • Lead Therapy Systems Engineering efforts for a complex, active medical device
  • Understand human-factor engineering to translate user needs into system requirements
  • Develop and maintain product requirements, design descriptions and other technical documentation
  • Collaborate to maintain the product Design History File (DHF) of an active medical device
  • Collaborate in Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.

Requirements

  • University degree in Engineering or solid experience in relevant roles within medical device development (R&D)
  • 5+ years of working experience in product design, development, and/or testing in the area of medical device
  • Strong understanding of System Design and Therapy development
  • Experience with design for manufacturing and reliability is preferred
  • Ability to communicate effectively within an international and multi-site environment
  • Welcome is experience related to regulations and standards (ISO 13485, IEC 62366, IEC IEC, ISO CFR801, MDD, MDR)
  • Fluent knowledge of English both verbal and written