FMI Lead Program Integrator
Core
Lead end-to-end execution of complex Field Medical Intervention (FMI) and Recall programs in a highly regulated medical device environment, ensuring closure readiness and compliance.
Role type
Senior Program Leader (FMI/Recall)
Builds
Audit-ready program closure documentation and improved operational workflows
Domain
Medical Devices / Regulatory Compliance / Program Management
Required skills
Cross-functional program leadership, risk management, schedule and budget control, stakeholder influence, regulatory compliance, Lean methodologies, digital enablement, resource coordination
Preferred skills
Medical device Quality Management Systems (ISO 13485), recall management, Computed Tomography/Molecular Imaging knowledge, PMP/Lean Six Sigma certification, workflow automation
Technologies
Microsoft 365, program planning tools, dashboards, document management systems
Responsibilities
Own end-to-end program execution from initiation to closure, develop integrated program plans and critical paths, lead cross-functional teams across Engineering and Quality, manage risks and escalations, drive closure readiness and compliance, operate disciplined execution management systems, lead resources and continuous improvement initiatives
Seniority
Senior, hands-on IC