R&D Therapy System Principal Engineer
3 settimane fa
Visionary Role at Baxter
Baxter is revolutionizing kidney care and other vital organ support. As a key member of our team, you will play a crucial role in shaping the future of medical devices.
About the Role
The R&D Therapy System Principal Engineer will be responsible for executing system engineering tasks during the life cycle of an active medical device, from design to development and sustaining.
This person will collaborate with multidisciplinary teams and work in a global, dynamic, and fast-paced environment.
Key Responsibilities
- Join Therapy Systems Engineering efforts for a complex, active medical device
- Understand human-factor engineering to translate user needs into system requirements
- Develop and maintain product requirements, design descriptions, and other technical documentation
- Collaborate to maintain the product Design History File (DHF) of an active medical device
- Collaborate in Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed
Requirements
- University degree in Engineering or solid experience in relevant roles within medical device development (R&D)
- 5+ years of working experience in product design, development, and/or testing in the area of medical device
- 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
- Welcome experience related to regulations and standards (ISO 13485, IEC 62366, IEC 60601.1 IEC 60601.2.16, ISO 14971.21CFR801, MDD, MDR)
- Fluent knowledge of English both verbal and written
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