Product Safety Quality Engineer
Core
Ensures safety and compliance documentation for hospital patient monitoring products using advanced risk assessment methods.
Role type
Product Safety Quality Engineer
Builds
Safety and compliance documentation for medical device products
Domain
Medical devices / Hospital patient monitoring
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DFMEA, FMEA, FTA, root cause analysis, ISO 13485, ISO 14971, IEC 62304, IEC 82304, Design for Quality (DFQ), risk management analysis
Preferred skills
Master's degree in relevant field, 5+ years experience in medical device industry
Technologies
FMEA, FTA, ISO 13485, ISO 14971, IEC 62304, IEC 82304
Responsibilities
Evaluate product designs to uncover safety concerns and potential hazards; Apply advanced risk assessment tools like FMEA and FTA; Perform comprehensive reviews to ensure product safety is thoroughly addressed; Identify and document risks that could impact reliability and compliance; Use systematic methodologies to analyze and mitigate potential safety issues in hospital patient monitoring products
Seniority
Mid-level, hands-on IC