Beschreibung
Software Risk Management Engineer MedicalOur client is working on innovative software solutions to deliver surgeons additional insights.
Duration: 3 months with possible extension
Location: Canton of St. Gallen, Switzerland
Responsibilities
- Collaborate with development and change management teams to assess risk for medical device software
- Provide feedback to product development teams regarding observed design-related and user-related failure modes
- Maintain close interaction with the engineering, human factors and quality functions to contribute to product development and improvement.
- Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971
- Support Risk Management / Cybersecurity activities from product Concept through product obsolescence.
Required
- 5+ years of experience as software risk management engineer
- Experience and working knowledge of medical device quality standards such as IEC 62304, ISO 13485 and ISO 14971
- Experience of software risk analysis and management per ISO14971 for medical device software developed using Agile software development process
- Experience of software development methodologies and lifecycle processes
- Working understanding of FDA, GMP, and ISO 13485
- Extremely strong problem-solving skills
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.