Zach Oferrell

About Zach Oferrell

Experienced Engineering Leader with a demonstrated history of success in the medical device industry. Skilled in DMAIC, Verification and Validation (V&V), Manufacturing Execution Systems, and FDA GMP. Strong engineering professional with a Master of Business Administration (M.B.A.) from University of Utah - David Eccles School of Business.

Experience

1. Sr Director of Business Excellence

   Edwards Lifesciences

   Nov 2025 — Present · Irvine, CA, US

   As the Sr. Director of Business Excellence, I lead enterprise-critical transformation efforts that strengthen operational performance, elevate engineering excellence, and build sustainable, high‑trust systems across our manufacturing network. My work focuses on enabling teams to operate with clarity, data‑driven discipline, and a shared commitment to world‑class execution.I partner closely with Operations, Engineering, Quality, and cross‑functional leaders to define and deploy future‑state structures, standard work frameworks, and performance systems that scale across sites. This includes driving alignment around Product & Process Engineering (PPE) and Plant Operations Engineering (POE), accelerating our automation and digital strategy, and ensuring our teams are equipped with the tools, processes, and support needed to deliver with precision and reliability.My priorities include:• Building and deploying plant‑standard structures that enhance technical ownership, reliability engineering, and cross‑site consistency.• Leading organizational transformation by simplifying processes, clarifying roles, and removing friction for frontline teams.• Strengthening engineering and operations interfaces, improving handoffs, and enabling faster, higher-quality decision-making.• Driving continuous improvement through measurable systems, strong visual management, and coaching of leaders at all levels.• Creating alignment across global sites, ensuring practices, policies, and engineering approaches are scalable and integrated.• Developing high-performing teams rooted in trust, transparency, and a shared commitment to excellence.I’m passionate about building organizations that combine technical rigor with human-centered leadership—where people do their best work because the systems, culture, and clarity enable them to succeed.

Education

• Georgia Institute of Technology

  B.S., Biomedical Engineering

  2004 — 2009

• University of Utah - David Eccles School of Business

  Master of Business Administration (M.B.A.), Business Administration and Management, General

  2012 — 2014

Skills

• Process Capability
• Manufacturing Operations
• Agile & Waterfall Methodologies
• Biomedical Engineering
• Heart Valves
• Gage R
• Agile Project Management
• Validation
• Visual Basic for Applications (Vba)
• Sprint Planning
• Process Improvement
• Continuous Improvement
• Engineering
• Design Control
• Six Sigma
• Product Launch
• Equipment Qualification
• Spc
• Fda Gmp
• Catheters
• Lean Manufacturing
• Minitab
• Dmaic
• Operational Excellence
• Manufacturing Engineering
• Simulations
• Quality System
• V&V
• Mes
• Fda
• Pfmea
• Technology Transfer
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Manufacturing
• Medical Devices
• Capa
• Agile Methodologies
• Iso 13485
• Clean Rooms