FMI Lead Program Integrator
GE Healthcare
GE Healthcare
Shape the future of healthcare as an FMI Lead Program Integrator at GE HealthCare. This hands-on role empowers you to independently manage complex field-action programs from initiation to closure within a highly regulated landscape. You will transform ambiguity into actionable plans, foster global cross-functional collaboration, and meticulously control schedule, cost, risk, and compliance. Deliver predictable program outcomes with minimal leadership oversight, demonstrating sound judgment and effective problem-solving.
Continuously enhance the FMI/Recall operating model through Lean thinking, data-driven insights, streamlined workflows, digital tools, and responsible AI adoption. Join an organization dedicated to improving lives where innovation and a collaborative spirit drive healthier realities worldwide.
- Lead end-to-end FMI and Recall programs, ensuring execution, closure readiness, and adherence to quality management system procedures and program plans. - Develop and maintain integrated program plans, including critical paths, milestones, resource forecasts, budgets, and governance mechanisms. - Drive global stakeholder alignment to achieve approved commitments. - Serve as the primary program leader across Engineering, Quality, Regulatory Affairs, Service, Supply Chain, Product, and regional teams, fostering collaboration and issue resolution. - Proactively identify and manage risks, issues, dependencies, and changes, providing clear recommendations for leadership escalation. - Ensure closure readiness and compliance through reconciliation activities, objective evidence, approvals, and regulatory documentation. - Implement a disciplined execution management system using dashboards, program linearity, and fact-based performance reviews. - Coordinate execution priorities with Closure Analysts, consultants, and external partners, optimizing resource utilization and driving improvements. - Deliver concise, decision-oriented program updates, risk assessments, and recovery plans to leadership. - Identify opportunities for workflow simplification, automation, and enhanced operational visibility within FMI/Recall processes. - Partner with Digital, Software, Data, AI, Cybersecurity, Quality, and Validation teams to define requirements and support solution deployment. - Champion the adoption and value realization of digital and AI-enabled solutions.
- Bachelor's degree in Engineering, Science, Business, Operations, or a related discipline, or equivalent relevant experience. - Minimum 9 years of experience in engineering, service, quality, operations, or program/project management. - At least 5 years of experience leading cross-functional projects or programs in a regulated environment. - Demonstrated ability to manage schedules, risks, actions, resources, budgets, and stakeholder communication for complex programs. - Strong execution discipline, organizational skills, and the ability to manage multiple priorities concurrently. - Effective written and verbal communication skills, including presenting program status, risks, and recommendations to leadership. - Proven ability to influence without direct authority in a global, matrixed organization. - Fluent in written and spoken English.
Preferred Qualifications: - Working knowledge of medical-device Quality Management Systems, product lifecycle, risk management (ISO 13485, ISO 14971), and post-market regulatory expectations. - Experience supporting medical-device field actions, recalls, or regulated service deployments. - Experience with program management or continuous-improvement certifications (PMP, PMI-ACP, SAFe, Lean/Six Sigma). - Experience with workflow automation, analytics, or AI-enabled business initiatives.
GE Healthcare
Healthcare