Carlos Diaz

About Carlos Diaz

Manufacturing Engineering and Operations leader with more than 20+ years of experience driving operational performance in highly regulated medical device manufacturing environments. I specialize in transforming, manufacturing operations through engineering leadership, process optimization, automation, and Lean manufacturing principles while ensuring full compliance with FDA and ISO quality systems.Throughout my career I have led cross-functional engineering organizations responsible for manufacturing process development, equipment qualification, process validation, and continuous improvement initiatives that improve yield, reduce cycle time, and strengthen operational reliability. My work focuses on aligning engineering, quality, and production teams to build scalable, robust manufacturing processes capable of supporting both commercialization and sustained production growth.My experience spans medical device manufacturing, pharmaceutical production, and high-precision engineering environments where quality, repeatability, and regulatory compliance are critical. I have extensive expertise in Lean manufacturing transformation, process validation (IQ/OQ/PQ), statistical analysis, root cause investigation, and implementation of automation and capital equipment strategies to improve productivity and operational efficiency.I am passionate about building strong engineering teams, developing future leaders, and creating a culture of continuous improvement where engineering and operations work together to solve complex manufacturing challenges and deliver high-quality products that ultimately improve patient outcomes.Core areas of expertise include:• Manufacturing Engineering Leadership• Medical Device Manufacturing (FDA / ISO 13485)• Lean Manufacturing & Operational Excellence• Process Validation (IQ / OQ / PQ)• Automation & Capital Equipment Implementation• Continuous Improvement & Root Cause Analysis• Cross-Functional Engineering and Operations Leadership• Process Development and Manufacturing Scale-UpI am always interested in connecting with leaders and organizations focused on advancing manufacturing innovation and operational excellence in the medical device and life sciences industries.

Experience

1. Manufacturing Engineering Manager

   Terumo Aortic

   Nov 2020 — Present · Sunrise, FL, US

   Manufacturing Engineering Manager leading cross-functional teams supporting high-volume, FDA-regulated medical device manufacturing. Scope includes Manufacturing Engineering, Calibration, Production Maintenance, Cleanroom Operations, Facilities, and Packaging, with responsibility for operational execution, regulatory compliance, talent development, and business continuity.Drive organizational effectiveness through technical mentorship, performance management, and strategic resource alignment to meet production demand, quality requirements, and business priorities. Partner closely with Quality, Operations, Finance, Safety, and Facilities leadership to ensure uninterrupted manufacturing operations in a highly regulated environment.Deploy Lean manufacturing systems—including Kaizen, 5S, Standard Work, and TPM—to improve efficiency, equipment reliability, and operational discipline. These initiatives have delivered approximately $1.3M in operational cost savings within a single fiscal year across manufacturing, calibration, maintenance, and facilities functions.Lead and support FDA and ISO audits, ensuring compliance across process validations, manufacturing controls, and quality system requirements. Guide engineering teams through NCR and CAPA investigations, Test Method Validations (TMV), and IQ/OQ/PQ activities using data-driven root cause analysis to implement sustainable corrective actions.Served as Interim Facilities Manager during a leadership transition, assuming full responsibility for facilities engineering and operations. Directed maintenance teams and contractors, managed preventive and corrective maintenance programs, oversaw HVAC, utilities, cleanrooms, and environmental controls, led capital projects, managed budgets and vendors, supported regulatory inspections, and ensured emergency response readiness while maintaining operational stability.

Education

• University of Puerto Rico-Mayaguez

  Master's degree, Electrical Engineering

  2007 — 2007

• University of Puerto Rico-Mayaguez

  Bachelor of Engineering - BE, Mechanical Engineering

Skills

• Microsoft Office
• Quality System
• V&V
• Root Cause Analysis
• Design of Experiments
• Manufacturing
• Product Development
• Lean Manufacturing
• Dmaic
• Cross-Functional Team Leadership
• Engineering
• Medical Devices
• Capa
• Gmp
• Design Control
• Testing
• R&D
• Continuous Improvement
• Spc
• Six Sigma
• Minitab
• Solidworks
• Iso 13485
• Management
• Design for Manufacturing
• Validation
• Iso
• Fda
• Fmea