Lead manufacturing operations for several departments producing FDA-regulated critical medical devices for the global cardiovascular surgery market. Maintain safety, quality, productivity, cost control and regulatory compliance with direct responsibility for P&L. Utilize assets to meet corporate strategies and business plan. Enforce corporate policies, quality compliance, and government regulations. Maintain morale, maximize profits, and promote continuous improvements and efficient operations. Play a key role in the hiring and development of cross-functional team members. Serve as a key contact and point person with the FDA. Reporting to the VP of Operations provide leadership to seven direct reports and 200 indirect reports. Manage a $3.5 million capital expense budget and a $52 million annual variable expense budget.

Primary contact and host for FDA inspections and external audits including ISO audits.