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
Healthcare / Medical Devices / Respiratory Care
Deliverable
production ML models | product features
Required skills
System Design (MBSE/V-Model), Requirements Management, System Architecture, Risk Analysis (DFMEA), FDA Quality System Regulations (ISO 13485/14971/10993/18562, IEC 62366), Test-Driven Design, Hardware/Software/Consumables Integration
Preferred skills
Sleep Therapy/Ventilation product experience, Master's degree in Engineering
Technologies
MBSE, V-Model, DFMEA, ISO 13485, ISO 14971, ISO 10993, ISO 18562, IEC 62366
Responsibilities
Translate user and business requirements to product requirements and system architecture; Allocate derived requirements to subsystems; Conduct system-level design reviews; Own system-level defect analysis and remediation; Manage technical risk via DFMEA and risk control measures.
Seniority
Senior, hands-on IC