We are partnering with a Digital Health Software Developer to cover a cross over 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 along side a company who is digitalization the world of clinical trails and patient data!
Responsibilities
- Interprets customer, business, and compliance needs to define technical design requirements for software as a medical device
- Identifies essential and critical requirements, and effectively trace requirements to design and test cases
- Leads definition of high quality and comprehensive system verification and validation strategy fo software as a medical device
- Leads risk analysis activities, including hazard analysis, FMEA, FTA, and risk-benefit analysis
- Leads design reliability and strategy
Experience needed :-
- Highly experienced with software-based medical device systems
- Experience providing technical leadership
- Experience launching medical device solutions
- Understands human factors guidance and IEC standards
- Deep understanding of ISO 13485, ISO 14971, IEC 60601, IEC 62366, , requirements, , and application to software-based medical devices
- Familiarity with health and data privacy regulations
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