Risk Manager for Medical Device Software

• Performing risk analysis for the state-of-the-art software for medical devices developed for treating cancer patients worldwide.
• Performing and organizing risk management activities for software components.
• Working closely with development teams on the identification and mitigation of software risks.
• Preparing risk management files and other technical documentation.
• Supporting the quality assurance aspect of the medical device software development according to relevant regulatory and standard requirements.

• Experience with the risk management process.
• Familiarity with different risk management techniques.
• Familiarity with applicable standards, e.g., ISO 14971.
• Experience in writing clear, concise and comprehensive technical documentation.
• B.Sc. in Computer Science, Electrical Engineering, Physics or other related technical disciplines.
• Fluency in spoken and written English.
• Developed communication skills and an open mind for discussion and team collaboration.

Familiarity and experiences with the following topics below are considered a great advantage. We offer training and coaching opportunities to learn about them as part of your career too.

• Medical or other highly-regulated projects.
• Software engineering.
• Quality assurance.
• Change management.
• Systems engineering.

• Employment contract for an indefinite period with a six-month probationary period.
• A competitive and periodically updated salary tailored to your skills, experiences, and results.
• Interesting work full of challenges in an international working environment.
• A work environment with flexible working hours and remote work.
• Opportunities to work abroad, on-site.
• High-impact learning culture: regular in-house and external training sessions and a team of international professionals eager to help you grow.
• Lots of recreational after-work activities, unlimited coffee, soft drinks, fruit, therapeutic massage, other well-being goodies.
• COSYlab events (Teambuildings, CosyPicnic, New Year’s Party, … ).
• Casual atmosphere with friendly faces where you can completely “be yourself”.