Ingénieur Système
Core
System Engineer ensuring integration, regulatory compliance, and validation of medical software solutions to deliver safe and effective products.
Role type
System Engineer (Medical Devices)
Builds
Medical software solutions and integrated system components
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System engineering practices, Requirements management, V&V methodologies, Agile/SDLC lifecycle knowledge, Risk management principles, System architecture interpretation, Regulatory standards knowledge (ISO 13485, ISO 14971, 21 CFR 820, EN 62304), English fluency
Preferred skills
Experience as Product Owner or Test/Validation Engineer
Technologies
Requirements management tools
Responsibilities
Translate client and clinical needs into system requirements, Ensure end-to-end traceability between requirements and validation, Coordinate system integration activities, Collaborate with cross-functional teams (Product, Dev, V&V, Quality, Regulatory), Participate in design reviews and risk management, Contribute to Design History File (DHF) documentation
Seniority
Mid-level, hands-on IC