Executive responsibility for Global manufacturing operations of medical devices and the management and maintainence of the regulatory affairs program.Global Operations managementSterilization programISO 13485, 60601, EMI, INMETRO, CFDA, KFDA FDA, MDD, MDRCost reductionGlobal medical device complianceR & DInventor 3 medical device - US patentsFDA 510k product approvals

Enginivity was a start-up medical device company which designs, manufacturers and supplier of the enFlow medical fluid and blood warmer. Responsibility’s include manufacturing operations, purchasing, quality systems and regulatory. (domestic and international) Sample contributions include: • Implemented and maintained quality and regulatory internal systems• Achieved product CE certification MDD compliant (TUV Rheinland)• ISO 14385 and ISO 9001-2000 certifications• FDA 510K device approvals• Brought product lines from engineering prototype to production currently producing 2 million disposable sterile cartridges per year and is fastest growing product (sales) introduction in the company’s history• Developed supplier and contract mfg partners (domestic and China)• Developed and managed supply chain and logistics globally• Developed continuous cost of goods reduction strategy. Reduced disposable cartridge costs by 60% in a two year period.

Vice President with primary responsibility of managing and growing operations including, manufacturing, global sourcing, supply chain, materials management, facility’s, Human Resources, IT, Logistics and Quality. Sample Contributions: Established global supply chain and partnership• Implemented 5S’s program• Achieved ISO 9001-2000 certification• Reduced COGS by over 30% • Improved operating efficiency with process mapping• Established China base of operations for importing of product.• Reduced freight costs by 25%

Senior manager with responsibility of executive management of all operations including manufacturing, materials, logistics, supplier partnerships, global supply chain sourcing, manufacturing engineering, Quality, regulatory, traffic and management and coordination of off-shore turn-key contract manufacturers. Sample contributions: Consistently reduced COGS on all product lines including a 50% reduction of manufacturing cost on flagship product (TempTale) over a four-year period.  Selected, partnered, implemented and managed offshore contract manufacturing facilities in Hong Kong, China and Malaysia.  Contributor on due diligence management team during the acquisition of Ryan Instruments.  Implemented as management representative a documented quality system, achieved ISO 9001 certification in less then 6 months and was awarded Level one Massachusetts Quality award. (Also global product certifications; UL, CE, TUV)

Ultrafiltration and liquid Chromatography systems