Biomedical Engineer
1 settimana fa
Vantive: Revolutionizing Kidney Care
Baxter is transforming its ~$5B Kidney Care segment into a standalone company, Vantive.* Vantive will leverage our nearly 70-year legacy in acute therapies and home and in-center dialysis to deliver best-in-class care.
As a member of the Vantive team, you will be part of a community focused on improving patients' lives worldwide. Our mission is to revolutionize kidney care and other vital organ support.
The Role
You will be responsible for implementing product quality activities within New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects for chronic and acute blood sets disposables.
Key responsibilities include:
- Participating in project core teams for NPD projects and design change controls as product quality representative.
- Performing product quality activities within NPD, SPO, and Regulatory Compliance projects.
- Reviewing documents for device history file issuing and maintenance.
- Ensuring compliance to applicable laws and standards.
- Quality approving design NCR/CAPA for product families assigned.
Requirements
For this role, we require:
- A degree in Engineering in the Biomedical field or Life sciences.
- Previous experience in the Med-Tech industry with focus on medical devices.
- Knowledge and experience of Quality System based on ISO 13485, FDA, CFR, GMP regulation, and MDSAP.
- Critical thinking, problem-solving, collaboration, communications, and negotiation skills.
What we bring
We offer a collaborative and innovative work environment, dedicated to improving patients' lives worldwide. Join us in revolutionizing kidney care and other vital organ support.
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