Puerto Rico
Goal-oriented operations leader with over 23 years of experience in the medical device industry, driving results across manufacturing, engineering, process improvement, and capital programs. Throughout my career, I have consistently delivered on regulatory, customer, and business expectations, while leading large, diverse teams through transformation and growth. As a certified Six Sigma Black Belt, I specialize in lean operations, cost reduction, process optimization, and new product introductions. My leadership has resulted in multimillion-dollar savings, operational efficiency gains, and sustained improvements in OEE and compliance metrics. Hands-on experience with FDA inspections, cGMP, ISO, QSR, 21 CFR Part 11/820, and GAMP standards, ensuring that operations not only meet but exceed stringent regulatory requirements. Fully bilingual in Spanish and English, I thrive in global environments and excel at building high-performing teams, mentoring future leaders, and leading change initiatives. Core Strengths: - Executive Leadership in Manufacturing & Engineering - Medical Device Operations & Regulatory Compliance - Lean Six Sigma, Continuous Improvement & Cost Reduction - Large-Scale Team Leadership (700+ employees, $225M+ COP) - Capital Programs, New Product Development & Technology Transfer - Talent Development, Engagement & Organizational Alignment I am passionate about creating value by transforming operations, enabling innovation, and ensuring compliance in highly regulated industries.
• Engineer responsible to maintain and improve several manufacturing processes, utilizing knowledge of product design, materials, parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards. • Supervision of exempt and nonexempt personnel as well as third party contractors. • Use statistical tools to analyze defect and complaint trends and implements innovative ideas to minimize rejects and improve customer satisfaction. • Perform financial analysis for decisions regarding quality and continuous improvement evaluations for the business unit. • Certified as Quality Auditor for both internal and external audits.
• Lead engineering support for inbound transfer projects into the Ponce facility. Activities included but not limited to equipment qualification, process parameters development, start-up support, and personnel training (mechanics and technicians). • Use Root Cause Analysis tools to identify and investigate operational problems affecting process, product, and/or customer. • Lead several validation activities for new and modified processes and equipment.
• Provide professional services in the area of pharmaceutical validation engineering to improve the operation and performance of the companies dedicated to manufacture biotechnological, oral products, parenterals, medical devices and others. • Customers; Cordis LLC, OMJ Pharmaceuticals, and Edwards Lifesciences.