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.
- 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
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- China (2 years)
- China (2 years)
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- Spain (1 year)
- Spain (1 year)
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- 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)
