Executive Advisor profile
Miguel is a manufacturing, quality systems and program management consultant, with over 30 years of experience in Pharmaceutical and Medical Device operations, assessing organization's critical business requirements, identifying deficiencies and potential opportunities, and developing innovative and cost-effective solutions for enhancing
Prior to joining LEC, Miguel spent first part of his career working for pharmaceutical companies (Baxter and Procter and Gamble) in manufacturing, engineering, quality systems and project management roles in United States and Puerto Rico. During the last 15 years, Miguel has also worked with Medical Device companies (Medtronic, St Jude Medical, Oscor
Inc.) in technical and leadership positions as Director of Operations, General Manager and COO, in US, Puerto Rico and Dominican Republic.
He has a broad range of experiences in manufacturing technologies and products such as:
– Liquids, Emulsions and Creams (Health and Beauty Care Products)
– Solid Dose Manufacturing/Products (Analgesics)
– Catheters, Guiding Sheaths and Introducers (Vascular / Peripheral applications)
– Pacemakers and ICD’s (Cardiac Rhythm)
– Implantable Leads (Pain, Heart, DBS)
– Mechanical/Tissue Valves (Heart valve repair/replacement)
– Diabetes Infusion Pumps and accessories (reservoirs/sensors)
– Implantable drug infusion pumps (pain management)
He received his Bachelor of Science degree in Industrial Engineering (BSIE) from the University of Puerto Rico. Has participated in several development programs on statistics (University of Tennessee), Leadership Development Program (Wharton Business School), Advanced Program/Project Management (Procter & Gamble). During the last few years, Miguel has provided consulting support and advice to Pharmaceutical/Medical Device companies in the United States, Puerto Rico and Caribbean in areas related to Quality Systems and Remediation Strategies, Business Strategy Development and Deployment, Manufacturing Operations, Lean Manufacturing Systems, and Program/Project Management.
Executive Advisor Profile
Eddie Ignacio is a highly diverse operational leader with over 40 years’ experience in the electronic, chemical, conversion, consumer lighting, access retail & professional product, and pharmaceutical / medical device industries. Prior to starting with Lean Enterprise Consulting Inc., Eddie was part of several major companies including: Intel, Western Digital, Johnson & Johnson, General Electric and WernerCo. He is recognized for transforming global operations systems profitably and productively. Throughout his career held both domestic and international assignments with assignments held in Puerto Rico, USA, Mexico, Ireland, Italy, Brazil, Netherlands and Switzerland.
Eddie has a Bachelor of Science: Electrical Engineering from the university of Puerto Rico (Mayaguez Branch). He is a certified Six-Sigma Master Black Belt since 1995 who has trained over 250 professionals around the world. Fully Bilingual: English & Spanish In his last role as Executive Vice-President of Operations / Chief Operating Officer, Eddie was responsible for establishing short / long term business objectives and optimizing human capital at all levels. His areas of expertise include, amongst other things, the following:
– Worldwide Operations & Manufacturing
– Global Procurement & Sourcing
– Start-ups & turnarounds
– Global Logistics & Supply Chain
– Lean Manufacturing & Six-Sigma
– Quality Assurance & Process Excellence
– Acquisitions & Joint Ventures
– Regulatory Compliance
As an internal and external consultant, Eddie has been providing training and consulting advice to companies in the United States, Asia Pacific and Europe in areas related to Six-Sigma, technical writing, operational principles, ISO Quality Systems, leadership, and others.
Executive Advisor profile
Roberto Correa has extensive experience in Medical Device Operations and Quality System Operations including Supplier Quality Management, Manufacturing Management, Strategic Planning and Development, Organizational Alignment and
Prior to starting with Lean Enterprise Consulting Inc., Roberto was part of two major companies: Johnson & Johnson – a global leader in health products where he gained his medical devices experience during his 34 year association working in Brazil, United States, Mexico and Puerto Rico and project management in Germany, France, Scotland, Netherlands, Mauritius, India, and China, and them with CR BARD a multinational medical device company during his 4 year association working in United States, Mexico and Puerto Rico .
Device specific experience includes a broad range of class I, II and II products as:
– Urology products (Foley Catheters & Catheter Accessories, Urinary Collection Products, Urological Monitoring Systems, Wound Drainage and Drainage Tubes)
– Targeted Temperature Management
– Peripheral Vascular systems (Vascular Grafts, Angioplasty Catheters, Stents, Implanted Ports, Enteral Feeding Devices, Central Venous Catheters)
– Access Systems (Dialysis Catheters, PICC Lines)
– Wound closure systems (Surgical Sutures, staples, and topical glue)
– Breast Implants and Surgical meshes.
He received his Bachelor of Science degree in Civil Engineering from the FVE (Brazil) and MBA from Fundacao Getulio Vargas (Brazil).
As a consultant, Roberto has been providing training and consulting advice to medical device companies in the United States and Latin America in areas related to Quality Systems Strategy, quality systems requirements (ISO / FDA / ANVISA) , QS assessment and compliance, compliance gaps remediation, quality metrics, and human error reduction, regular FDA inspections, audit programs, , supplier selection and management.
Vivian Garcia Taylor
Executive Advisor Profile
Vivian is an experienced and successful Human Resources professional with a career spanning over 25 years working with global, multinational companies in almost all industries with expertise working internationally especially with Latin American countries, Europe and Asia. She is a diverse, multicultural individual with an extensive international and U.S. Human Resources background as a value added Strategic HR Business Partner and consultant developing and leading high performance teams. She excels in her ability to communicate and collaborate closely with all levels of management partnering closely with CEO’s, COO’s, CFO’s and the Senior Executive Teams of Fortune 500 companies like American Airlines, Clorox (subsidiary of P&G), DHL, Fox Networks Group, Lucent Technologies and The Walt Disney Company to date.
Vivian has provided critical insights and recommendations in her Executive coaching and consulting roles to achieve and exceed business results and add value to any organization. She is highly skilled in all the HR disciplines including proactively anticipating operational issues and providing actionable solutions to complex business and employee issues with extensive experience conducting investigations on various compliance issues. Her expertise is in creating, leading and managing high performance leaders and identifying high potential individuals through assessments and individualized career and development initiatives. She has subject matter expertise in:
– Recruitment and Selection
– Employee Onboarding initiatives
– Compensation and Benefits
– Learning and Development
– Talent Identification and Management
– Employee Relations matters and company investigations
– Employee engagement recommendations
– Company policy and compliance issues
– Social responsibility and Community Affairs
– Work/Life Balance initiatives
– Mergers and Acquisitions
Vivian possesses advanced skills and expertise in transforming and driving organizational change throughout the Mergers & Acquisitions process. She has excellent interpersonal, oral, and written communication skills in multiple languages.
She received her Bachelor of Arts from the University of Florida and is currently completing her Executive Coaching Certification with the College of Executive Coaching.