Sr. 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 / Pharmaceutical
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, regulatory compliance (ISO 13485, 21 CFR 820, MDR), vendor management, project scheduling, technical leadership
Preferred skills
IEC 60601, ISO 14971, IEC 62304, V-model implementation, context diagrams, interface management, error budgeting, sensitivity analysis
Technologies
Requirements management tools
Responsibilities
Lead user and stakeholder needs definition, conduct use case analysis, manage traceability and standards coverage, integrate third-party development activities, perform system risk assessments and use error risk assessments, ensure design validation meets safety and regulatory requirements, provide technical leadership and guidance to less experienced personnel, manage project schedules and identify risks
Seniority
Senior, hands-on IC with leadership responsibilities
