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Archiviertes Projekt - Software Risk Management Engineer Medical

Firmenname für PREMIUM-Mitglieder sichtbar

Februar 2020

Mai 2020

CH-St. Gallen

auf Anfrage




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


* 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.


* 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.


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