New York City Metropolitan Area
For over a decade, I have served as the primary operational partner to the CEO, scaling a bootstrapped medical device startup into a high-volume, multi-facility industry leader. I specialize in the intersection of aggressive enterprise growth and uncompromising regulatory compliance—building the automated facilities, Quality Management Systems, and high-performance cultures required to sustain a 20x revenue multiplier. I am a hands-on change agent who believes that operational excellence requires both cutting-edge technology and exceptional human capital. I have directed multi-million-dollar CapEx expansions, including international technology transfers for Class III Medical Device Manufacturing and advanced Swiss CNC manufacturing centers. Concurrently, I treat FDA compliance as a competitive advantage, navigating multiple rigorous audits with zero Form 483 observations and securing numerous 510(k) clearances. Beyond physical infrastructure, I am passionate about modernizing operations from the inside out. Whether I am coding an AI-driven (LLM) application to eliminate customer approval bottlenecks, implementing enterprise ERPs, or building a proprietary online academy to promote 85% of our facility leadership from within, I build systems that scale. I thrive in environments where data-driven strategy meets daily factory-floor execution.
Chief operational partner to the CEO, driving the strategic scale of a bootstrapped medical device manufacturer into an industry leader. Currently direct operations at the flagship manufacturing center, ensuring predictable, high-volume production for a rapidly expanding enterprise workforce. Operational Scaling: Partnered directly with the CEO to drive a 20x enterprise revenue multiplier, scaling the workforce by 1,000%+ while managing a bootstrapped P&L. CapEx & Global Tech Transfer: Directed multi-million-dollar CapEx build-outs, including a 20,000 sq. ft. dual-purpose plant. Scaled core Swiss CNC production and executed an 18-month international tech transfer (South Korea) to establish a Class III sterile cleanroom for medical device manufacturing. FDA Compliance: Spearheaded the transition to strict cGMP standards, securing 8 Class II FDA 510(k) clearances. Successfully navigated 3 rigorous FDA audits with zero Form 483 observations. AI Innovation: Architected and coded a proprietary AI-driven application (Gemini LLM) to autonomously manage customer design approvals, ensuring strict adherence to rapid 3- to 14-day manufacturing SLAs. Systems Implementation: Led the end-to-end launch of the company's first inventory ERP system and an e-commerce platform to inject self-sustaining cash flow during rapid expansion phases. Data-Driven KPIs & Talent: Overcame regional talent scarcity by building a proprietary LMS ("Creoacademy") with 90+ hours of curriculum, promoting 85% of facility managers from within. Architected a performance metrics system for objective headcount forecasting, compensation, and cross-training.
Research, design, implement management initiative to capitalize on client need for assistance dealing with litigation and contracts. Manage client relations and project contract agreements; serving as a subject matter expert on legal matters concerning client lawsuits. Create framework for conducting legal and financial analysis. Develop negotiation strategies for settlements in consultation with attorneys.
Manage and streamline marketing and research initiatives for Liquified Natural Gas Vehicular Tank Development. Conduct market analysis and assessment on current industry competition to optimize the development and delivery of the highest thermal performing LNG tank. Monitor and control throughout product development life cycle. Administer and ensure accuracy in various ad-hoc file and technical reports.
Manage, monitor, and control from initiation to close out the construction of a $2M office building. Conduct external communication with vendors. Streamline hiring and coordination with more than 26 contractors. Conduct due diligence and negotiation of all contracts on in individual basis. Ensure timely completion of weekly reports for submission to owner. Inspect and confirm acceptance of all completed work with governmental entities and expert judgment. Organized schedules and monitored project milestones. Spear head all resolution of issues.