We are currently working with an International Digital health solution company which works with clients in the Medical Device and Pharmaceuticals industry. Our client is looking for a System Engineer within Medical devices to support their team.
Some of the responsibilities are below:
- System verification and validation for software as a medical device
- Risk analysis activities, including hazard analysis, FMEA, FTA, and risk-benefit analysis
- Interprets customer, and compliance needs to define technical design requirements for software as a medical device
The key experience needed for the role:
- Strong software-based medical device systems experience
- Deep understanding of ISO 13485, ISO 14971, IEC 60601, IEC 62366
- Good knowledge of cybersecurity requirements, and application to software-based medical devices
- Excellent practical experience with The frameworks such as Angular JS, Android/iOS Mobile dev or web development
- Familiarity with health and data privacy regulations
