Therapy Systems Engineering Lead
2 settimane fa
Transforming Kidney Care with Baxter
At Baxter, we are revolutionizing kidney care by building on our nearly 70-year legacy in acute therapies and home and in-center dialysis. Our goal is to provide best-in-class care to the people we serve.
The R&D Therapy Systems Principal Engineer will play a crucial role in executing system engineering tasks during the life cycle of an active medical device, from design to development up to sustaining. This person will collaborate with multidisciplinary teams and work in a global, dynamic, and fast-paced environment.
Key Responsibilities
- Execute system engineering tasks for an active medical device
- Collaborate with multidisciplinary teams to develop and maintain product requirements, design descriptions, and other technical documentation
- Maintain the product Design History File (DHF) of an active medical device
- Participate in Risk Management activities to ensure design and process shortcomings are identified and addressed
Requirements
- University degree in Engineering or relevant experience in medical device development
- 5+ years of experience in product design, development, and/or testing in medical devices
- 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
- Familiarity with regulations and standards (ISO 13485, IEC 62366, IEC 60601.1, IEC 60601.2.16, ISO 14971, 21CFR801, MDD, MDR)
- Fluent knowledge of English
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