Software Risk Management Engineer Medical

This job has now expired please search on the home page to find live IT Jobs.

Software Risk Management Engineer Medical Our client is working on innovative software solutions to deliver surgeons additional insights.Duration: 3 months with possible extension Location: Canton of St. Gallen, Switzerland ResponsibilitiesCollaborate 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. Required5+ years of experience as software risk management engineerExperience 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 13485Extremely strong problem-solving skills Sthree Switzerland is acting as an Employment Business in relation to this vacancy.