Michael Fuller
Program Director - Endovascular Robotics @Siemens Healthineers
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WORK HISTORY
Program Director - Endovascular Robotics @Siemens Healthineers
Newton, MA, US
Accountable for the design, development, regulatory approval, and commercialization of a next-generation neurovascular robotics platform and pipeline. Oversee a highly complex, enterprise-critical program, including product strategy, development execution, and long-term platform expansion. Direct a program team of 70+ in R&D, PMO, clinical, regulatory, QA, and operations. Hold end-to-end program ownership for development and commercialization of a neurovascular robotics platform, guiding program from early technical discovery through FDA and EU MDR regulatory approval and launch. Primary executive communication lead for Endovascular Robotics, delivering clear, actionable updates on progress, risks, regulatory readiness, and financial performance to senior leadersKey Achievements Reoriented the organization from prototype-focused technology exploration to disciplined product design and commercialization, establishing clear product direction and executional precision. Rebuilt program scheduling and execution methodologies, shifting from task classification to causation-based planning, improving on-time milestone achievement. Established program-level financial controls covering development costs, operational expenses, COGs, and long-term commercialization viability, maintaining budget performance. Lead and manage the high-profile co-development partnership between Siemens Healthineers and Stryker Neurovascular, creating an integrated robotics and device ecosystem designed to integrate our company strengths and deliver complete clinical solutions across imaging, robotics and devices. Initiated and led a critical technical solution initiative in response to FDA feedback, integrating new technology into the existing platform within six months and successfully preserving program viability that would otherwise have been terminated.
EDUCATION
Lafayette College
Bachelor of Science Degree in Mechanical Engineering
Worcester Polytechnic Institute
Master of Science Degree in Mechanical Engineering - Design & Manufacturing
SKILLS
ABOUT MICHAEL FULLER
Senior Level Program and Project Management Leader Senior Level Program and Project Management Leader with expertise in medical devices, surgical robotics, and life sciences. Proven record of leading large, enterprise-critical portfolios and complex, multi-year programs from early technology discovery through product development and regulatory approval into commercialization and sustainable manufacturing. Background includes work with global organizations overseeing multimillion-dollar budgets, managing large cross-functional technical teams, and serving as the central execution authority aligning engineering, clinical, regulatory, quality, manufacturing, business, customer, and commercial stakeholders. A highly respected people leader and change agent, distinguished for building and leading PMOs, standardizing product development and design control frameworks, ensuring regulatory compliance, and restoring underperforming programs to full executional health. Effectively translate strategy into structured, scalable execution by strengthening program discipline and driving accountability for hardware and software development in FDA- and EU MDR-regulated environments. Leadership style blends technical depth in robotics and advanced surgical technologies with strong business acumen, executive communication, and an operational excellence focus. Grounded in Six Sigma Black Belt training and fluency across both Agile and Waterfall methodologies.Skills:Product Development, Project Management, Program Management, Risk Management, Process Development, Design Control, Business Control, Statistical Analysis, Design for Six Sigma, Lean Manufacturing, Requirements Management, Issue Management, Cross Functional Development & Management, Structured Problem Solving, Communication. Medical Device Regulatory Standards: Risk Management (ISO 14971); Biocompatibility (ISO 10993), Safety Compliance & Essential Performance (IEC 60601); Electrical Safety & Essential Performance (IEC 60601-1); SW Verification (ISO 62304); Quality Management (ISO 13485); FDA Regulations/Quality Management (21 CFR 820); EU Medical Device Regulations (EU MDR).Software Tools: Microsoft Office (including Teams, Visio & Project), Jira/Confluence management software, ProChain Project software, JAMA requirement management software, Arena & Agile design control softwares, CAD (ProE/Creo, SolidWorks, Autodesk), LabView, Minitab, Moldflow, PLC Design, ANSYS, MATLAB, Mathcad, Keyshot.
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