Functional Safety & Software Risk Manager (m/w/d)
Core
Systematic management of software-related risks in the development of dialysis devices to ensure product safety and regulatory compliance.
Role type
Functional Safety & Software Risk Manager
Builds
Dialysis devices for hemodialysis, peritoneal dialysis, and acute care
Domain
Medical devices / HealthTech / Dialysis
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software risk management, Hazard analysis, FMEA, Regulatory compliance (ISO 14971, IEC 62304), Cross-functional coordination, Audit support, Team training
Preferred skills
MedTech industry experience, Global team collaboration
Technologies
MS Office
Responsibilities
Plan and maintain software risk management per ISO 14971/IEC 62304, Identify and document software hazards, Define and track risk control measures, Coordinate software FMEAs, Support internal/external audits, Train development teams
Seniority
Mid-Senior, hands-on IC