R&D System V&V Principal Engineer
Overview
This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.
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Support for Parents
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Continuing Education/ Professional Development
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Employee Heath & Well-Being Benefits
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Paid Time Off
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2 Days a Year to Volunteer
Success Profile
What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Courage
- Action Oriented
- Collaborates
- Cultivates Innovation
- Manages Ambiguity
- Drives Results
R&D System V&V Principal Engineer
Vantive: A New Company Built on Our Legacy
Since last year, Baxter has been on a journey to separate our 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.
*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.
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
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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