Principal, Product Safety Risk Management
Core
Senior individual contributor providing technical leadership and expert execution of product safety risk management for regulated and non-regulated medical imaging software devices across the product lifecycle.
Role type
Principal, Product Safety Risk Management (Senior IC)
Builds
Medical imaging software devices (SaMD) compliant with global regulatory standards
Domain
Healthcare technology / Medical Devices / Software as a Medical Device (SaMD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 14971 risk management, hazard identification, risk analysis, benefit-risk assessment, regulatory interpretation (21 CFR, MDR, Canada), design controls integration, cybersecurity risk, post-market surveillance, FMEA, fault tree analysis, audit support, stakeholder influence, technical mentorship
Preferred skills
Advanced degree in engineering/life sciences, certification in medical device safety, agile development experience, cloud-based solutions experience, global regulatory expectations knowledge
Technologies
Jira, Xray Test Management, Microsoft 365
Responsibilities
Lead complex risk management analyses and documentation (hazard ID, risk evaluation, control strategies), serve as principal technical advisor on design controls and release readiness, integrate clinical/human factors/cybersecurity evidence into safety practices, evaluate risk control effectiveness and traceability, provide senior expert review for post-market safety activities (HHEs, complaints, FSCAs), develop safety metrics for management review, lead technical contributions to regulatory submissions, mentor team members on risk management principles, support internal/external audits and inspections
Seniority
Principal, hands-on IC with strategy & mentorship