Carlos Gutierrez
Senior Director, Engineering @ Edwards Lifesciences
About
Versatile, results oriented Product Engineering and Management leader with 25+ years of experience in the development and manufacture of products chiefly in the medical devices industry. - Skilled in the product development, packaging engineering, program management, product engineering, and manufacturing best practices. - Solid record of success in operational performance optimization and continuous improvement initiatives. CERTIFICATIONS Six Sigma Black Belt – DFSS / DMAIC Certified Professional Supply Management (CPSM) CORE COMPETENCIES Strategic & Tactical Leader • Engineering Management Medical Devices Packaging Engineering Process Validation & Sustaining Engineering Product Development Lifecycle • Program Management Global Operations Alignment • International Manufacturing Plant Transfers Mechanical Engineering • Antimicrobial Technologies Medical Devices Design Control • Product Pipeline Development FDA, cGMPs, ISO13485, ISO11607, Quality Systems High Performance Team Leadership • Single Use Medical Devices Development KPI & Performance Metric Strategies • Operational Excellence & Continuous Improvement Initiatives
United States
Irvine
Medical Device
Medical Devices, FDA, Design Control, Six Sigma, R&D, Cross-functional Team Leadership, Product Development, Lean Manufacturing, Commercialization, Design of Experiments, Product Launch, Continuous Improvement, Manufacturing, Market Development, Validation, Quality System, ISO 13485, V&V, CAPA, Strategy
Experience
Senior Director, Engineering
Edwards Lifesciences
Irvine, California, United States
Director, Engineering
Edwards Lifesciences
Irvine, California, United States
Senior Manager, Engineering
Edwards Lifesciences
Irvine, California, United States
R&D Product Development Manager, Strategic Development
Medtronic
Mansfield, MA
Lead the R&D efforts of the Wound Care, Urology, and Open Suction franchises. Manage product innovation and technical development of medical devices for domestic and international markets. Direct a group of three product development engineers, three lab technicians, and three designers to successfully develop and manufacture in house or outsource medical devices.
Program Manager
Covidien (Medtronic Minimally Invasive Therapies Group)
Mansfield, MA
Headed new product development programs from concept to launch for medical disposable devices. Achieved product quality and financial objectives for the Medical Supplies Global Business Unit. Ensured senior management informed of project status and negotiated resources and schedules.
Principal Packaging Engineer
Covidien (Medtronic Minimally Invasive Therapies Group)
Mansfield, MA
CENTER OF EXCELLENCE (2008) Implemented packaging world class methods and standards across the seven Global Business Units. Oversaw implementation and compliance with corporate branding initiatives. Established corporate procurement strategies for packaging materials and equipment. Managed operations of two packaging laboratories and the package stability program. Directly supervised packaging engineer supporting manufacturing facilities in Europe and two laboratory technicians. PRINCIPAL PACKAGING ENGINEER (2004 - 2007) Oversaw the packaging development activities for eight manufacturing facilities within the Medical Supplies Business Unit. Managed two engineers, one technician, one stability coordinator, and the corporate packaging laboratory. SENIOR PACKAGING ENGINEER (2002-2004)
Senior Manufacturing Engineer
Covidien (Medtronic Minimally Invasive Therapies Group)
Tijuana Area, Mexico
In charge of 20 production lines, various projects, and plant transfers of medical products, primarily in the Urology and Open Suction areas. Prepared validation (OQ/PQ) protocols and reports, defined product specifications, BOMs, costing, production layouts, line balance, and plant budget. Managed two manufacturing engineers.
Senior Project Engineer
Samsung Electronics
Tijuana Area, Mexico
Responsible for the screen process of two TV cathode-ray tube production lines. Managed the installation of two CRT (20” & 21” screens) high volume production lines. Coordinated a team of maintenance engineers, technicians, and contractors to achieve the key process indicators (KPI) of the department.
Education
Tecnológico de Monterrey
Mechanical Engineering / Electrical Engineering
Harvard University
Management and Administration
Carlos Gutierrez's Contact Information
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