Manuel Domenech
SVP Integrated Supply Operations @ MiniMed
About
Thirty years of progressive managerial experience in complex Domestic and International manufacturing operations leading transformations, restructuring, consolidations and evolutions in over 15 global plants. Solid track record of consistently exceeding goals by engaging individuals and teams to go beyond in a full compliance and ethical work environment. Strong emphasis on customers and how the enterprise drives value to them. International experience with Medical device & Pharmaceutical in the US, Asia and Latin America. Strong leadership and team building skills, results oriented, inspiring and visionary leader with excellent communication skills; an engaging and participative style with a strong focus on quality compliance, profitability, spending control, safety, and customer and employee satisfaction. Extensive experience with Quality and Regulatory Compliance system; well versed in Six Sigma, Lean Enterprise, Automation, Environmental Health and Safety programs. Extensive experience in Local and Central Government business collaboration and relationship both PR and International. A list of my core competencies include: Multi Site operation: >15 sites globally Productivity Improvements: Efficiency, Cost and Process Improvements Strategy Planning & Execution Supplier Negotiation Facility Start Up and Closure Project Management, large Capital Investment & Strategic Projects Quality System & Compliance Development Policy and Procedure Regulatory Management Available to discuss opportunities for either direct employment or consulting/contract work, please email me at manuel_domenech@me.com
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United States
Public Safety
GMP, ISO, CAPA, Continuous Improvement, Cross-functional Team Leadership, FDA, Corrective and Preventive Action (CAPA), Business Development, 21 CFR Part 11, Change Control, Aseptic Processing, Design of Experiments, DMAIC, Kaizen, Medical Devices, Manufacturing, Lean Six Sigma, Business Process Improvement, Strategic Planning, Management
Experience

SVP President Quality Assurance
Lead regional Quality Operations which includes Mexico, Colombia, Brazil, Costa Rica, DR and Canada Insure excellence around compliance with a strong business focus of adding value in everything the Quality function does Key accomplishments: Excellent regulatory results including warning letter resolution for medical device plant Extensive use of expert councils to drive standardization of management tools and value drive projects Reduced inventory by $2.5M through implementation of Parametric Release Reduced $650K in cost initiatives and $1M in human capital efficiency initiatives Implement and optimize the use of Complaint and CAPA quality systems Drive optimization of Quality function in the region

SVP Manufacturing Caribbean
Miami/Fort Lauderdale Area
Led cluster organization with 5 manufacturing operations located in Puerto Rico, Dominican Republic and Costa Rica with a strong business focus on driving value in everything we did. Managed over $450M VOP and over $1B sales. In addition, manufacturing delegate for Fluid Systems and Anesthesia franchises with over $3.2B in sales. Key accomplishments: Drive sharing of best demonstrated practices through expert councils around common value streams (molding, facility design, production lines, and others) Developed strategic plan that optimize manufacturing platform in Puerto Rico by transforming existing medical device plant into injectable solutions plant and using the investment to implement best demonstrated practices in the industry. Liaised with local government organizations in Puerto Rico, Dominican Republic and Costa Rica to obtain tax advantages initiatives to match current business needs in those locations. Implemented and executed Enterprise Management System, holistic approach to continuous improvement through a combination of Malcolm Baldrige principles, Lean, 6S and A3 Management.

SVP Global Manufacturing Medical Devices
Round Lake, Illinois
Directed 7 medical device plants in Malta, Tunisia, Singapore, Puerto Rico, Costa Rica and Canada. Volume of production (VOP) of these operations was $300M in support of over $750M in sales. Reported to VP Medical Products Operations and member of Global Leadership Team (GLT). In addition, manufacturing delegate for Fluid Systems franchises with over $2.4B in sales. Key Accomplishments: Successfully managed supply activities with over 97% fill rate, cost reduction initiatives producing 5% of VOP margin improvements. Saved over $10M per year through execution of network optimization: closure of site, set up new facility in the Dominican Republic and multiple product transfers between Canada and remaining sites. Liaised with local government organizations in Puerto Rico, Dominican Republic and Costa Rica. Successful integrated 2 manufacturing plants into the network; one site focused on electromechanical pumps and the other on pharmacy compounding devices. Supported development, introduction, launch and growth of new medical device product focused on peripheral line access valves. Product represented over $200M in sales for the Medical Device business.

VP Manufacturing China
Shanghai City, China
Led 4 sites in China including 2 joint venture (JV) companies with a total VOP of $107MM and 1800 associates with a strong business focus on driving value in everything we did. Drive value to the China business through: Succesful integration of new joint venture focused on Nutrition products Achieve best cost of IV fluids for the company Execute technology conversion of IV container packaging technology Drive expansion plans to support 50% growth YoY for 8 consecutive years Localized all plan leadership
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