Software Risk Analyst / Manager (medical device exp)
Contract Duration: 6 months (outside IR35)
Location: Remote Working
This MedTech company are currently seeking regulatory approval to launch a truly revolutionary device, across multiple geographies. The device has been in development for many years and they now need two people to produce software risk analysis deliverables in compliance with the appropriate standards (ISO 14971, IEC 62304 & IEC/TR 80002) and regulations.
Your role will be to create software hazard analysis by:
- Reviewing software requirements for potential risk, as well as reviewing implemented software items for potential fault-scenarios (utilising the generic software hazards of IEC/TR 80002).
- Analysing software cause and effects for hazardous situations and harm (in line with a pre-defined platform hazard lists).
- Identifying potential risk control measures.
- Re-evaluating residual probabilities in line with existing risk management system.
NOTE: This role will not include any activities relating to software development or testing. Instead it is needed to complete risk analysis and draft risk mitigations that can then be further defined and implemented by our client’s internal software team.
Skills & Experience required:
- Experience writing software medical device technical documentation such as software risk analysis and software requirement specs.
- Knowledge of ISO 14971, IEC 62304 and IEC/TR 80002-1.
- Understanding of software practices in a regulated environment.
- Working knowledge of Java and/or Embedded C is needed, with Android experience a bonus (although please note that detailed knowledge of the entire software development lifecycle is not necessary).