Left Ventricular
Assist Device
(LVAD)

Established and directed a comprehensive Project Management Office (PMO) to oversee the full development lifecycle of a Class III Left Ventricular Assist Device (LVAD) from initial concept through FDA-approved clinical trials (Q1 2024) under Investigational Device Exemption (IDE) protocols. This life-saving cardiac device required rigorous adherence to medical device design controls (21 CFR 820) and regulatory standards throughout a multi-year, multi-million-dollar development program.
 

Strategic Leadership & Cross-Functional Coordination:
Led a Core Team of 40+ members spanning R&D engineering, clinical affairs, regulatory compliance, quality assurance, and operations to ensure seamless product development execution. Implemented a hybrid Waterfall-Agile methodology tailored to hardware and software development streams, optimizing delivery efficiency while maintaining regulatory rigor. Facilitated weekly technical reviews and monthly executive leadership presentations, maintaining full transparency on program status, risk profile, and resource allocation.

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Program Planning & Execution Excellence:
Architected comprehensive project work breakdown structures (WBS), identified critical paths using MS Project, and prioritized 200+ tasks across concurrent development streams. Established data-driven dashboards tracking key performance indicators (KPIs) including milestone completion rates, budget variance, and design control compliance metrics. Improved operational cadence through standardized review processes, reducing decision cycle time by 30% while ensuring thorough technical and regulatory evaluation.

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Technical & Regulatory Leadership:
Defined product specifications, design inputs, and performance requirements based on user needs analysis and competitive benchmarking. Oversaw 15+ design verification protocols and 8 validation studies conducted with external test laboratories and clinical sites. Created technical and business process solutions for complex challenges spanning biocompatibility testing, electromagnetic compatibility (EMC), cybersecurity risk management, and human factors validation.

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Stakeholder Management & FDA Engagement:
Served as primary organizational liaison in technical discussions with the FDA Center for Devices and Radiological Health (CDRH), third-party suppliers, clinical investigation sites, and hospital partners. Successfully navigated Pre-Submission meetings, IDE submissions, and clinical trial protocol reviews, securing FDA authorization for first-in-human studies. Managed vendor partnerships for critical components including blood pumps, controllers, and drive systems, ensuring supply chain continuity and cost optimization.

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Recognition & Impact:
Awarded Employee of the Year (2021, 2022) for exceptional program leadership and cross-functional influence. Successfully transitioned project from development through regulatory approval, positioning the company for clinical trial enrollment and eventual market entry in the high-growth ventricular assist device market.