Senior leader with 20+ years engineering experience, emphasizing in medical device manufacturing and product design. I have managed cross functions teams in Process Development, Production Support, Continuous Improvement and New Product Release from design through manufacturing stabilization. Strong business acumen focusing on quality, cost, sustainability and customer satisfaction. Demonstrated track record for large scale, multi-faceted project management.
Manager & Lead Engineer: Factory launch in Vietnam for Automated Blood Collections manufacturing (25,000 sq. meter facility)
Direct cross functional teams in the Startup, Validation and Stabilization of core production processes (Apheresis & whole blood collections)
Accountable for hiring and training initial key positions within Engineering, Production, Quality and Maintenance.
Facilitate collaboration among global partners to achieve factory goals: Japan & U.S. (management), India (technical support), Ireland (legal manufacturer) & Vietnam (workforce)
Developed engineering training programs involving travel & coaching at external global sites.
Execute on company goals to achieve quality and cost targets
Lead process engineer during audits and inspections
Lead designer in the development, fabrication and testing of next generation medical device manufacturing line
Intelligent automation based design:
Live RFID feedback and control of critical to quality processes
Auto recognition and re-configuration for product change overs
Developed visual based work instructions for 80 person assembly line and EtO sterilization process.
Enhancements to exiting lines using lean principles
Product Design: Engineering liaison with French Blood Establishments (EFS) to develop product for national market.
International Standards Organization (ISO) committee participant in the design and development of a new connector for anticoagulant solutions (ISO/DIS 18250-8)
Relocated manufacturing lines from external suppliers (national and international moves)
Commercial: Successfully negotiated multiple sales offers worth 2.5 million euros . Analyzed market and defined future growth strategies. Wrote sales offers and negotiated contracts with end customers.
Technical: Defined product evolution and implemented new advancements
Quality: Drove continuous improvement of product range through collaboration with customer, design and manufacturing departments
Worked with "Customer Solutions Team" to develop new products for the automotive, medical, packaging and construction industries (regulators, filters, lubricators & actuators)
Process owner for multiple manufacturing lines
Responsible for OEE and process enhancements using lean principles
Directed cost reduction projects, sourcing components through Asian and Latin American suppliers
Successful transfer of 3 production lines to low cost manufacturing in Queretaro, Mexico
