Senior Systems Engineer
Core
Lead systems engineering for drug/device combination products, integrating multiple disciplines to ensure robust patient-centric design and performance.
Role type
Senior Systems Engineer (Medical Devices/Pharma)
Builds
Drug/device combination products
Domain
Healthcare / Medical Devices / Pharmaceuticals
Required skills
Systems engineering principles, IEC 60601, ISO 14971, IEC 62304, ISO 13485, 21 CFR 820, MDR, risk management, requirements definition, system architecture, interface management, V-model implementation, project scheduling, vendor management
Preferred skills
Experience with third-party development partners, multi-cultural awareness, design validation, error budgeting, sensitivity analysis
Technologies
IEC 60601, ISO 14971, IEC 62304, ISO 13485, 21 CFR 820, MDR
Responsibilities
Lead user and stakeholder needs definition, conduct use case analysis and traceability, define system/sub-system requirements, integrate third-party development activities, perform system architecture and integration, manage risk assessments and design validation, provide technical leadership and guidance to less experienced personnel
Seniority
Senior, hands-on IC with leadership responsibilities