Freddy Menendez
Technical Transfer Engineer @Alcon
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WORK HISTORY
Technical Transfer Engineer @Alcon
US
EDUCATION
UC Irvine
Bachelor's degree, Biomedical/Medical Engineering
ABOUT FREDDY MENENDEZ
AI X MedTechSupplier Quality | Manufacturing Engineering | Process Optimization | Global Supply Chain | Computer Software Validation Engineering solutions that drive supplier excellence, manufacturing efficiency, and product quality.As a Supplier Quality and Manufacturing Engineer, I specialize in supplier development, process industrialization, and global manufacturing transfers across regulated industries. With experience spanning PCBA manufacturing, injection molding, optomechanical systems, and medical devices, I lead initiatives that optimize supplier performance, enhance product reliability, and scale production for high-demand environments.Key Expertise: Supplier Qualification & Development: Managing global supplier networks, conducting audits, and ensuring compliance with ISO 9001, ISO 13485, IPC-A-610, and FDA/EU MDR standards. Manufacturing Process Optimization: Leading high-volume process transfers, SPC implementation, and cost reduction initiatives across multiple manufacturing sites. PCBA & Electromechanical Systems: Sustaining 150+ PCBA configurations, training engineers/technicians as an IPC-A-610 Certified Trainer, and ensuring supply chain resilience. Risk & Quality Management: Driving CAPA, SCAR, and NCR resolution, implementing FMEA strategies, and ensuring seamless supplier integration into quality management systems. Computer Software Validation (CSV) & MES Integration: Leading validation of manufacturing execution systems (MES), software automation, and electronic process control to ensure compliance with 21 CFR Part 11 and GAMP 5.Currently, as a Global Technical Transfer Engineer at Alcon Laboratories, I manage multi-million-dollar process transfers and software validation projects across global sites, ensuring scalability, efficiency, and regulatory compliance. My previous roles in supplier quality, MES integration, and PCBA manufacturing have equipped me with a strong foundation in lean manufacturing, process validation, and supplier industrialization strategies.I am passionate about leveraging advanced manufacturing techniques, data-driven decision-making, and supplier collaboration to drive innovation in high-tech industries. Let’s connect and explore how we can collaborate!
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