Sr. Director of Manufacturing

• Feb 2021 - Present

Director of New Product Development

• Nov 2008 - Nov 2020

• Promoted 5 times in 10 years, establishing Laguna Niguel as the center of excellence for balloon catheter new product development. • Managed company’s first next generation balloon PTA platform from feasibility through product launch. Product scope included 174 SKU's. • After Confluent merger, built development department from a team of 4 engineers to a department of 25 people which included project management, catheter engineering, balloon engineering, technicians and operators. • Duties included department financial P&L monthly reviews. • Department grew revenue over 400% in 2 years. • Established standardized practices in new product development and program management. • 10 years’ experience with customer interactions from project inception, design verification, regulatory submission and production transfers. • Served as Director of Operations for balloons, catheters, and extrusion for 4 years. In 3-year, timeframe improved OTD from 70% to 92% for a growth of 104%. • Project lead in the construction of 4 class 8 clean rooms. Show less

Coils, Catheters, Stents Production Manager

• Jul 2005 - Dec 2008

Coils, Catheters, Stents Production Manager [4/2007 – 12/2008] • Managed a 2 shift FDA production environment of 200 employees, including 5 supervisors. • Managed through transfer of acquired Atherectomy production line. • Received FDA approval on the production at a new facility by laying out new production lines, training operators, managing validation builds and assuring all clean room requirements were met. • Increased productivity 300% by improving yields from 68% to 98% by leading a cross functional team with R&D and manufacturing engineering to identify new opportunities. Coils Production Supervisor [4/2006 – 4/2007] • Supervised over 50 people in the production of medical devices. Duties include; production planning, reporting production results, enforcing FDA requirements, training, DHR reviews, and audits. • Experience focused on new product lines from design verification through process validation for neuro-embolic coils. • Raised production levels 100% in 8 months. Raised overall yield rates 15% by identifying problem areas. Senior Manufacturing Engineer [7/2005 – 4/2006] • Established new product introduction and qualification processes and procedures. Researched and implemented processes utilizing new technologies of laser welding, vacuum drying, miniature assembly, platinum/NiTi Heat Treating. Completed (IQ/OQ/PQ) and software validations. Show less

Senior Manufacturing Technology Engineer

• Jun 2000 - Jul 2005

• Experience in lean, six sigma, and new product introductions. • Accomplishments include project management for $3.5MM capitol expense for a new orthodontics line. Process development and optimization in brazing, micro-assembly, automated assembly, and tumbling. • Experience in lean, six sigma, and new product introductions. • Accomplishments include project management for $3.5MM capitol expense for a new orthodontics line. Process development and optimization in brazing, micro-assembly, automated assembly, and tumbling.