Systems Engineer
Core
Develop and sustain respiratory ventilators and sleep therapy devices, ensuring product safety, reliability, and quality through systems engineering.
Role type
Senior Systems Engineer (Medical Devices)
Builds
Respiratory ventilators and sleep therapy devices
Domain
Medical Devices / Respiratory Care
Required skills
System Design (MBSE/V Model), Requirements Management, FDA Quality System Regulations (ISO 13485/14971), Risk Analysis (DFMEA), System Integration, Verification and Validation, Hardware/Software/Consumables Engineering
Preferred skills
Sleep Therapy/Ventilation product experience, Master's degree in Engineering
Technologies
MBSE, V Model, ISO 13485, ISO 14971, IEC 62366
Responsibilities
Translate user and business requirements to product requirements and system architecture, Allocate derived requirements to subsystems, Conduct system-level design reviews, Manage technical risk via DFMEA, Own system-level defect analysis during integration phases
Seniority
Mid-Senior, hands-on IC