Lavori attuali relativi a R&D System V&V Principal Engineer - Medolla MO - BAXTER
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R&D System V&V Principal Engineer
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V&V Leader
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V&V Leader
2 mesi fa
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System Process Engineer
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Medolla (MO), Italia Baxter A tempo pienoVantive: 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...
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Global Service Engineering Engineer
2 mesi fa
Medolla (MO), Italia BAXTER A tempo pienoSummary As a Global Service Engineer for Acute Platform, you’ll provide technical support and technical training on Dialysis devices, to Service and Sales Organizations by plans and priorities established by the Global Service Engineering Manager in charge of the product line. You’ll support Regional Master Trainers, Product Specialists, etc.,...
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System Process Engineer
1 mese fa
Medolla, Italia Baxter A tempo pienoVantive: 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...
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System Process Engineer
1 mese fa
Medolla, Italia Baxter A tempo pienoVantive: A New Company Built On Our LegacyBaxter 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...
R&D System V&V Principal Engineer
2 mesi fa
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.
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.
Summary
The R&D System V&V Principal Engineer will play a key role in the confirmation by examination and provision of objective evidence that the medical equipment (i.e. Dialysis machine) is complying with regulations and specification at system level. You will collaborate with multidisciplinary teams of engineers and work in a dynamic environment.
What you'll be doing
You'll follow all the phases of Verification and Validation at system and sub-system level of a medical product, from the impact analysis, through the definition of the test activities up to the preparation of all the documentation in line with the regulatory/standard requests and the QMS.
The V&V activities include:
- 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 cross-functional and/or cross-sites teams
- Support on internal and external Audit
- Management of instruments/tools
What you'll bring
- 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
- Able to communicate effectively, both verbally and in writing, within an international and multi-site environment
- Teamworking approach, Problem-solving attitude and ability to organize and prioritize tasks
