Medical Device V&V Expert
1 settimana fa
Vantive - A New Chapter in Baxter's Legacy
Baxter is embarking on a transformative journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive. This new entity will leverage our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to those we serve.
We believe Vantive will not only solidify our position in the kidney care space but also offer meaningful opportunities for those who join us. As a Vantive Verification and Validation (V&V) Leader, you will play a pivotal role in ensuring the flawless performance and regulatory compliance of our innovative electromechanical medical products.
Your Key Responsibilities
- Coordinate the V&V team as technical leader
- Verify technical requirements
- Validate intended use and user needs
- Ensure safety system verification and compliance to 60601-2-16
- Verify Risk Control Measures
- Verify Labeling and Training material
- 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
Your Qualifications
- Masters in Electronic Engineering or Biomedical Engineering
- ISTQB certificate preferred
- 5+ years of experience in R&D, System V&V, and medical device products
- 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 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 preferred
- Excellent communication and teamwork skills
About Vantive
Vantive is a new company built on Baxter's legacy, committed to providing best-in-class care to those we serve. We are a world-class R&D organization dedicated to improving medical products, and we are looking for exceptional talent to join our team.
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