What you’ll be doing
- 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.
What you’ll bring
- 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 is 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
More Information
- Experience Level Junior
- Total Years Experience 0-5
- Radio field Option 1
- Dropdown field Option 2
- Multiple Select field Option 3
- Checkbox field Option 2
