Lead Engineer, Systems
Core
Define system requirements, architecture, and specifications for complex medical devices and healthcare systems, ensuring compliance with regulations and quality standards.
Role type
Lead System Engineer (Medical Devices)
Builds
Complex medical devices and healthcare systems
Domain
Medical Technology / Healthcare Systems
Deliverable
production ML models | product features | infrastructure
Required skills
System engineering principles (V-model), requirements management, risk analysis, system architecture definition, regulatory compliance (FDA, CE, ISO 13485), requirements management tools (DOORS, Polarion), system modeling (SysML, UML)
Preferred skills
None stated
Technologies
DOORS, Polarion, SysML, UML
Responsibilities
Define and refine system requirements and architecture; Decompose requirements into sub-system specifications; Oversee system integration, verification, and validation; Conduct technical reviews of design and test deliverables; Identify and mitigate technical risks
Seniority
Senior, hands-on IC with leadership responsibilities