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.
Process Engineering Manager
Terumo BCT
Since 2013
Full-time
Ho Chi Minh
Vietnam
- 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
Sr. Design Engineer
Terumo BCT
2008
to 2013
- 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
- Live RFID feedback and control of critical to quality processes
- 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)
Product Manager: Aircraft Cooling & Heating Systems, Jetway Mounted
Ciatesa: CIAT Group (Spain Division)
2007
to 2008
- 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
Manufacturing Engineering Manager
IMI Norgren
2005
to 2007
Shanghai
China
- Managed startup of global engineering and manufacturing center in China
- Startup of 6 high volume production lines (pneumatic actuators)
- Qualification of Asian suppliers: Injection molding, tooling and raw materials
- Developed international training program for new engineers
Senior Design Engineer
IMI Norgren
2001
to 2005
United States - Colorado
- 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
- Designed components for injection molding
Design / Project Engineer
Conal Corporation
1999
to 2001
United States - Colorado
- Designed custom automated testing equipment for the can making industry
- Heavily involved in physical fabrication, testing and on-site customer startups
- Conducted customer site training for operators and maintenance technicians
- CAD Operator:
- 3D modeling and design of automated machinery
- 2D facility layouts
- 3D modeling and design of automated machinery
- Geometric Dimensioning and Tolerancing (GD&T) per ANSI Y14.5
Mold Tooling Designer
Protocast Inc.
1997
to 1999
- Solid background in molding and casting processes
- Designed magnesium and aluminum prototype molds for medical, automotive and aviation industries
Department Manager: Intelligence Division
United States Marine Corps
1990
to 1994
- Supported intelligence operations during high stress situations over extended periods
- Participated in Operation Restore Hope, Somalia (1992-1993)
- Received two certificates of commendation for outstanding leadership and performance
- Manage multi-national engineering teams in overseas factory startups (China & Vietnam)
- Medical Device Design and Manufacture
- Medical device validations supporting FDA registrations
- Project management in support of global customers
- Project & resource load balancing
- Process Optimization
- Tailored Manufacture for Japanese Markets
- Global Engineering Experience
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- United States
- United States
-
- China (2 years)
- China (2 years)
-
- Spain (1 year)
- Spain (1 year)
-
- Vietnam (3+ years)
- Vietnam (3+ years)
- Lean and Six Sigma Methodologies, Green Belt
- Design for Manufacture
- Validations per ISO 13485 for medical device manufacture: IQ, OQ & PQ
- Design for injection molding
- Corrective Action Preventative Action (CAPA)
- Statistical Process Control (SPC)
- Design of Experiments (DOE)
- Overall equipment effectiveness (OEE)
- Process failure mode effects analysis (PFMEA)
- Language: Fluent in English and Spanish
- Cleanroom ISO 8 (class 100,000) compliance
- Sterilization of medical devices (Ethylene Oxide and Steam)
