Program Manager - Systems
Core
Leading the full product development lifecycle of medical device capital systems from concept through commercial launch, ensuring compliance with FDA, EU MDR, and ISO standards.
Role type
Senior Program Manager, Medical Device Capital Systems
Builds
Medical device capital equipment and system-level products
Domain
Medical Devices / Capital Equipment / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Cross-functional program leadership, Medical device regulatory pathways (FDA, EU MDR, ISO 13485), Design control and risk management, Manufacturing readiness and transfer, Strategic roadmap planning, Stakeholder negotiation, Budget and resource allocation, Critical path analysis
Preferred skills
Robotic surgery experience, PMP certification, ALM/PLM systems, Agile methodologies
Technologies
ALM/PLM systems, Project management tools
Responsibilities
Partner with technical and functional leaders to shape program strategy and roadmap; Lead cross-functional teams through concept development, design iteration, and design transfer to manufacturing; Drive manufacturing readiness, supply chain coordination, and launch planning; Ensure project deliverables meet US and global medical device standards and quality system requirements; Optimize WBS and program schedules across interdependent projects; Coach peers on stakeholder engagement and program management tools
Seniority
Senior, hands-on IC with strategic leadership