We currently have a requirement for a Senior Manager, Systems Engineering to join a MedTech Organisation on a 6 months contract based in either London or Cambridge, UK. Please note that after the 6 months the client is looking to offer a Permanent contract. During the current Corona Virus situation this role will begin remotely.
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
Key Skills Required:
- 7+ years of software-based medical device systems experience
- 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, , cybersecurity requirements, , and application to software-based medical devices
- Familiarity with health and data privacy regulations
- Relentless drive to win and bring a product to market
- Start-up mentality to wear multiple hats and do what's required to get the job done
- Passionate customer focus
