We are partnering with a Digital Health Software Developer to cover across over a period of a permanent staff member starting. They are a cutting edge software developer and have a large client base which is ever-growing.
This is a great opportunity to work alongside a company who is digitalization the world of clinical trials, patient data and helping to solve COVID-19.
The SaMD Architect will be working with the product and software engineering team to ensure different customer solutions are designed, architected, documented and implemented according to medical device design and development requirements from regulatory bodies. These solutions include mobile, web, and web services.
Responsibilities:
- Architect, document and lead development of software-based medical devices
- Software development life-cycle, sub-system architecture and design specifications, SW requirements, unit and integration testing, software FMEA, reliability analysis, and root cause analysis.
- Complete software verification and validation
- Software design and development, test and life cycle management
Experience needed:
- 5+ years of software development experience
- 5+ years of experience in software medical device development classified as Class 2 and/or Class 3 medical device
- expertise with MD regulations - ISO 13485, ISO 14971, Cybersecurity, IEC 62366, and IEC 62304
- Expertise with Software FMEA process
- Expertise in writing architecture and design specifications for Class 2 or Class 3 medical device software
Please be aware that applicants need to hold a valid EU passport or have a residency in Switzerland.
