Job Detail

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Stellentyp:

freiberuflich

Dauer:

3 Monate +

Einsatzort:

CH

Starttermin:

14.04.2020

SOLCOM zählt zu den führenden Technologiedienstleistern in den Bereichen Softwareentwicklung, IT und Engineering. Seit mehr als 20 Jahren arbeiten wir als Partner global agierender Spitzenunternehmen aller Branchen und sind weltweit im Einsatz, wo Innovation entscheidet.

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.

Anforderungen:

• 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