Lead System Designer – AI COE
Core
Lead System Designer for AI-enabled medical imaging devices (Ultrasound, MR, CT) ensuring end-to-end product development from requirements to commercial release.
Role type
Senior System Designer (NPI Program Lead)
Builds
AI-enabled ultrasound and medical imaging devices and software
Domain
Medical Devices / Healthcare Imaging / AI
Deliverable
production ML models | product features
Required skills
System engineering, requirements management, design control, verification and validation (V&V), risk analysis, regulatory compliance (GxP), cross-functional program leadership
Preferred skills
New Product Introduction (NPI) regulatory compliance, Design History File management, GEHC Phase Review Discipline, global matrixed organization experience
Technologies
AI development frameworks, medical device software stacks
Responsibilities
Lead core team and design control process from requirements to design transfer; Develop requirements flow down, architecture/system design, and risk analysis; Ensure quality targets and technical risks are addressed; Validate GxP relevant applications and maintain validated state; Drive compliance/closure of Regulatory and Quality requirements before approving milestones.
Seniority
Senior, hands-on IC with program leadership