Software Risk Management Engineer Medical (m/w/d)

For one of our customers we are currently looking for a Software Risk Management Engineer Medical.

+ 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
+ Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971
+ Carry out Cybersecurity activities from product Concept through product obsolescence.

+ 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
+ Experience of software development methodologies and lifecycle processes
+ Working understanding of FDA, GMP, and ISO 13485
+ Fluent in verbal and written English

Konnten wir Ihr Interesse wecken? Dann freuen wir uns auf die Zusendung Ihres aussagekräftigen Qualifikationsprofils unter Angabe Ihrer Stundensatzvorstellung.