Senior Systems Engineer
Core
Lead systems engineering for drug/device combination products, ensuring robust patient-centric design, integration of third-party activities, and regulatory compliance.
Role type
Senior Systems Engineer (Medical Devices/Combination Products)
Builds
Drug/device combination products for patient use
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems engineering principles, risk management planning, system architecture, requirements definition, design validation, IEC 60601/ISO 14971/IEC 62304/ISO 13485/21 CFR 820 compliance, V-model implementation, interface management, project scheduling, vendor management
Preferred skills
Experience with device design controls, operational simulations, error budgeting, sensitivity analysis, multi-cultural team collaboration
Technologies
IEC 60601, ISO 14971, IEC 62304, ISO 13485, 21 CFR 820, MDR
Responsibilities
Define user and stakeholder needs, conduct use case analysis, manage system/sub-system requirements, integrate third-party development activities, perform risk assessments, ensure design validation, provide technical leadership and mentorship
Seniority
Senior, hands-on IC with leadership responsibilities
