Project Management Manufacturing Operations - Lean Implementation & Continuous ImprovementSupply Chain - Development & Risk Assessment Venture Capital - Medical Device Operations & Manufacturing Assessment

Medical Device start up company focused on developing the most advanced IV infusion pump platform.Responsible for establishment of Supply Base including CM's for IV pump and Sterile single use admin sets, Sourcing & Qualification of 40+ injection molding tools for product V&V and FDA submission support, Budget, CoGS and Capacity planning for market preparation and Board of Director communications.Supply Base included suppliers for Machined components, PCBA's, Capacitive Touch Screens, Plastic and Magnesium molded components located in U.S, Canada, China, India and Japan

Life Cycle Engineering & Technical Documentation Management

• New product launch, production relocations, sustaining engineering, production and budgeting. • $1M+ combined cost reduction & avoidance achieved at manufacturing sites through lean manufacturing principles and tools including: value stream mapping, standardized work, root cause analysis, and DMAIC principles.• $250k savings realized through effective project management for Windows XP EOL. Initiated and led cross functional team together with customer service to oversee product validation, inventory management and customer install base upgrade to Win7 platform.• Led environmental, health and safety team to perform gap analysis, hazardous assessment and communication to ascertain OSHA compliance.=====================================================Senior Director, Global Manufacturing - Miami, FL• Accountable for daily oversight including local and corporate goal attainment at U.S. and U.K based production facilities.• $500k cost savings achieved through successful transfer of operations from Florida facility to Boston in six month period.

• Drove production and sustaining engineering for 160 associate union facility utilized for manufacture of fiber optic and CMOS digital endoscopes for minimally invasive surgical procedures.• Successfully negotiated two 3 year teamsters union contracts.• Accountable for all aspects of 60 associate non-union facility for production of ENT devices.• Implemented matrix organizational structure designed to support value stream continuous improvement, sustaining engineering and new product introduction.• Core competencies: high precision optical manufacturing including glass, lens and fiber optics, clean room processing, sterile packaging and high complexity assembly.

• Relocated to Mexico to oversee start up of a 35,000 sq. ft. facility utilized for production of medical devices including: Suction/Irrigation equipment, disposable electrosurgical devices and accessories.• Responsibilities included: ROI analysis, budget and schedule development and adherence, facility design and oversight including clean room specification and installation, transfer of technology from U.S location, talent acquisition of engineering, quality, supply chain, facilities and production associates. • Hands-on management style resulted in on-time start up and product shipment.• Initiated and led Mexico team for development of lean culture to support continuous improvement through the utilization of a value stream based organizational structure.• Core competencies: Clean room assembly, sterile packaging, ultrasonic welding, epoxy bonding.=========================================================Technical Services Manager – Norwalk, OH • Responsible for manufacturing engineering, tool room, document control, facilities and maintenance.• Effectively structured operational support functions to facilitate production support, sustaining engineering and productivity improvements.• Member of initial core team to plan and facilitate lean transformation in partnership with Bowling Green State University. • Core competencies included: Machining, tool and fixture design, clean room processing, lens polishing and semi–rigid digital scope assembly.

• Responsible for direction and oversight of manufacturing engineering, mechanical and electrical assembly, planning, facilities, machining and tool room.• Performed master scheduling function in order to meet sales requirements and maximize available capacity.• Coordinated resources to facilitate order flow from BOM release through final product shipment.• Developed and managed capital and expense budgets in excess of $1M• Developed plant layout, equipment and manufacturing requirements for the $50M, 120,000 sq ft. facility.• Resided in Japan for two years while developing and overseeing six-month training programs for lead manufacturing associates.

• Completed two year production management development program in Menomonee Falls WI, followed by three years as production supervisor in Riverbank, CA.