System Integration & Verification Manager
Core
Lead system-level verification strategy, execution, and team development for ultrasound platforms to ensure product design outputs meet regulatory and quality requirements.
Role type
Senior System Verification Manager (Medical Devices)
Builds
Verified ultrasound platforms compliant with IEC 62304, ISO 14971, and NMPA standards
Domain
Medical Devices / Ultrasound / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System verification strategy, V-model lifecycle management, team leadership, regulatory compliance (IEC/ISO/NMPA), automation, resource allocation, cross-functional collaboration
Preferred skills
Biomedical engineering background, clinical validation experience, audit readiness management
Technologies
IEC 62304, ISO 14971, PDLM
Responsibilities
Define and govern verification entry/suspension/exit criteria, lead high-performing verification teams, ensure audit readiness for NMPA/IEC, partner with RA/Quality/System Engineering, drive automation and continuous improvement in verification methodologies
Seniority
Senior, hands-on IC with leadership