Andres L.
Principal Engineer Project Manager @Edwards Lifesciences
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WORK HISTORY
Principal Engineer Project Manager @Edwards Lifesciences
Led 6 junior engineers and 3 consultants and controlled $5M annual CAPEX budget for NPI/NPD, value improvement and product quality initiatives. Served as Subject Matter Expert (SME) in Validation and material certification processes. Supported Risk Management Board program and verified compliance with ISO 14971:2019, internal audits (21 CFR 820, ISO 13485, SOX), and external audits (FDA, DEKRA, customer audits).• Led supplier validation and qualification for plastic/elastomer molding and extrusion processes• Managed $5M CAPEX budget and delivered $3.5M+ in cost savings through NPI, VIP, and supplier improvement projects• Partnered with Procurement, R&D, and Quality to develop RCA/Action plan on supplier-related CAPAs and SCARs within 30 days• Standardized supplier audit and certification processes, reducing turnaround time by 3 months• Ensured compliance with ISO 13485, ISO 14971, 21 CFR 820, and FDA audit requirements• Supported Risk Management Board and component qualification efforts across multiple product lines
EDUCATION
UCLA Henry Samueli School of Engineering and Applied Science
Bachelor of Applied Science - BASc
Capella University
Master of Business Administration (MBA)
ABOUT ANDRES L.
Strategic bilingual professional supplying continuous improvement, risk mitigation, and compliance excellence. Adept at leading cross-functional teams, enriching quality systems integration, supplier quality management programs, NPI/NPD/ Value Improvement Projects, and empowering collaboration across engineering, regulatory, and operations teams. Proactive problem solver with keen eye for process optimization and commitment to efficiency, cost savings, and customer satisfaction. Control multimillion-dollar CAPEX budgets and lead project execution to enhance quality integration, streamline operations, and drive measurable advancements. Known for navigating complex regulatory landscapes, mentoring teams, and fostering culture of quality and innovation in high-stakes environments.
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