Lead Systems Engineer
Core
Lead systems engineering for next-generation Incubators and Warmers, translating clinical and regulatory needs into system requirements, architecture, and verification strategies for neonatal care devices.
Role type
Lead Systems Engineer (Medical Devices)
Builds
Next-generation Infant Care Incubators and Warmers
Domain
Medical Technology / Neonatal Care / Regulated Product Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems engineering, requirements management, hazard analysis, risk management, integration planning, verification, validation, design control execution, usability engineering, electromechanical systems knowledge, regulatory compliance (IEC 60601 series)
Preferred skills
Neonatal/maternal infant care device experience, human factors principles, reliability engineering, embedded systems, cybersecurity, manufacturability analysis
Technologies
IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 62366-1
Responsibilities
Lead system-level problem solving for neonatal care environments, develop and execute system integration strategies, support quality and regulatory activities including design reviews and audits, communicate technical risks and design tradeoffs, align cross-functional teams on engineering rigor, maintain focus on clinician workflow and newborn safety.
Seniority
Senior, hands-on IC with leadership responsibilities