Medical Device Manufacturing Excellence Summit

Greg Smith is Executive Vice President, Global Operations and Supply Chain at Medtronic. He is responsible for the performance and integration of all aspects of the company’s operations including Manufacturing, Supply Chain, Supply Management, Operational Excellence and Transformation, Enterprise Risk and Facilities, and Operations Quality.

Before joining Medtronic in April 2021, Greg was the Executive Vice President of U.S. Supply Chain at Walmart, one of the world’s largest and most complex supply chains. Greg transformed Walmart’s supply chain to be best in class, developing and implementing a comprehensive strategy that drove sales, achieved operational excellence, reduced costs, and that created an engaging, enabling, and empowering work environment.

Greg is deeply committed to diversity, equality, and the belief that a diverse workplace where everyone feels included results in stronger teams and the highest level of service to our patients, customers, and employees. He was recognized as a 2020 Diversity Leader by Diversity Journal (opens new window).

Before joining Walmart, Greg was Senior Vice President, Global Operations at The Goodyear Tire & Rubber Company, where he was responsible for 52 manufacturing facilities across four business units around the world. He successfully led the company’s global optimization program and implemented an enterprise manufacturing operating system, a global procurement program, and an enterprise planning and logistics approach.

In his more than 35 years of supply chain and operations experience, Greg has also transformed manufacturing, procurement, and logistics programs at companies including ConAgra Foods, United Signature Foods, VDK Frozen Foods, and Quaker Oats.

Greg earned his bachelor’s degree in finance from the University of Tennessee, Knoxville, and he currently serves on the College of Business advisory board. He serves on the GS1 Management Board and is the Vice Chairman of its Board Committee for Healthcare. Additionally, he serves on the board of directors for Advance Auto Parts, Inc. He is also a member of the Gartner Supply Chain Executive Advisory Board.

In his role, Viju is responsible for global operations, including manufacturing, direct procurement, regulatory affairs, quality assurance, sustainability, integrated business planning, logistics and advanced operations such as additive manufacturing technology development.

Prior to joining us, Viju served as Chief Supply Chain Officer and Senior Vice President at Verizon. Before his work at Verizon, Viju held key leadership roles at Intel in technology, supply chain and manufacturing operations.

Viju earned his doctoral degree from the University of Pennsylvania and dual graduate degrees (MBA, S.M. in electrical engineering) from the Massachusetts Institute of Technology’s Leaders for Global Operations program. He also holds a graduate degree (M.S.E. in computer science engineering) from the University of Michigan and a bachelor’s degree in engineering from the University of Kerala, India.

Aileen Barreto Rivera is a transformational global leader with extensive experience in Supply Chain and Quality within the Medical Devices and Pharmaceuticals industry. Since joining Johnson & Johnson in 1995, Aileen has held multiple roles of increasing responsibility across various business units including Orthopedics, Vision Care, Diabetes Care and Innovative Medicine with direct accountability of Manufacturing, Lean, Engineering, and Quality functions. Her professional journey spans across key locations, including Puerto Rico, Europe, and the United States.

Throughout her tenure, Aileen has successfully led numerous strategic projects, including operational readiness for key product launches, site start up strategies and significant efficiency improvements within the manufacturing landscape. Her leadership has facilitated remarkable accomplishments, during acquisitions, compliance improvements initiatives, as well as significant contributions to community initiatives, reflecting her passion for people. Aileen’s commitment to excellence is evident in her ability to drive performance and engagement while maintaining high standards of quality and customer satisfaction.

Her academic background includes a Bachelor of Science in Electrical Engineering from the University of Puerto Rico, as well as an alumni of notable leadership programs at J&J.

Paudie O’Connor is the Senior Vice President for Global Supply Chain at Boston Scientific, a position he has held since May 2022. In this role, he serves on the company’s Executive Committee and is responsible for leading the world-class Global Supply Chain team, comprised of thousands of colleagues guided by its purpose of delivering for patients. Paudie’s career in healthcare and medical technology has spanned over 26 years, serving in various roles across management, operations and engineering. Previously, Paudie served as Vice President, Planning and Customer Experience at Boston Scientific from January 2021 to April 2022 and multi-site vice president, Manufacturing from February 2015 to January of 2021. Prior roles in Boston Scientific included Vice President of the Clonmel, Ireland site from January of 2009 to February of 2015 and various engineering and operations positions in the U.S. and Ireland from 1998 to 2008. Prior, Paudie worked for Aer Lingus, PRI Automation and Integer. He is the current sponsor of the Massachusetts PRIDE employee resource group. Paudie earned a B.A. in Mechanical Engineering from Trinity College in Dublin and a master’s degree in industrial engineering from University College Dublin.

John Daley brings over 30 years of FDA-regulated industry experience to Compliance Architects. As Chief Quality Officer at JUUL Labs, he secured its groundbreaking ISO-13485 certification. John has led Quality at Johnson & Johnson, Boston Scientific, and IBM Watson Health, where he also oversaw Privacy and Security. With expertise in Design Controls, CAPA processes, combination products, medical devices, pharmaceuticals, and consumer goods, John offers a wealth of knowledge. He holds a BSME from the University of Rhode Island and an MBA from SUNY Albany.

Chester Zelaya is the Senior Vice President of Implant Network Global Operations at Edwards Lifesciences, overseeing global facilities that support both Surgical Heart Valve and Trans-Catheter Divisions. With over 30 years of leadership experience in the biopharmaceutical and medical device industries, Chester has a proven track record of driving operational excellence across diverse, multi-plant environments. Prior to joining Edwards, he held senior roles at Shire and Baxter, where he managed large-scale plasma manufacturing operations and led significant global initiatives. Chester also serves as a board member for Heart to Heart Global Cardiac Care, helping to expand access to life-saving cardiac treatments in underserved regions. His strategic vision, technical expertise, and commitment to building high-performing teams contribute to his success as a leader in the healthcare industry.

David Kunz was appointed Senior Vice President, Global Quality and Regulatory Affairs in May 2017. He is responsible for providing strategic and operational direction to achieve Quality and Regulatory Excellence across the organization and he chairs the Company’s Quality Excellence Steering Committee. Mr. Kunz joined the Company (then Zimmer) in 2011 as Vice President, Regulatory Affairs and Quality Assurance for the Spine division. He was appointed Senior Vice President, Global Quality, Clinical and Regulatory Affairs in April 2016.  Prior to joining Zimmer, he served as Vice President, Quality Assurance of Ecolab, where he led a supply chain network including nine chemical plants and two equipment plants. Previously, he spent 13 years at Guidant/Boston Scientific Corporation in a variety of leadership positions, most recently as the Director of Supplier Quality Assurance for the CRV Division. He began his career at the Naval Nuclear Propulsion Program Headquarters as a mechanical engineer. Mr. Kunz holds a Bachelor of Science and an MBA from the University of Minnesota. He is a certified Nuclear Engineer and previously was a certified Licensed Professional Mechanical Engineer.

In his role as Head of Supply Chain & Operations for Philips Image Guided Therapy Devices, Cory is responsible to lead a world-class supply chain organization and to drive operational excellence in support of the business goals, which are fully focused on providing patient-focused and market-leading solutions. His passion for building a high-performing team of supply chain and operational leaders is rooted in his belief that there is always a better, more efficient way to serve our customers. Prior to entering the diagnostic / therapeutic medical devices industry, Cory spent over 20 years in development and leadership roles in the medical device and automotive industries.

Dina is currently the Vice President of Regulatory Affairs for Terumo Medical Corporation where she oversees both US and global Regulatory Affairs. Prior to joining Terumo in 2008, Dina spent 17 years at the FDA as a reviewer and later a branch chief in the Division of Cardiovascular Devices. She also spent some time as a Sr. RA consultant prior to joining Terumo.

Dina holds a BS in Biomedical Engineering from The Catholic University of America and a Master of Business Administration from the University of Maryland.

Robert Popp is a seasoned professional with over 35 years of experience, including executive management, spanning medical devices, pharmaceuticals, and biologics. His expertise encompasses service support, sales, marketing, quality, and manufacturing. Known for his customer-centric approach, Robert leverages strong analytical skills and business acumen to drive improvements in customer experience and regulatory compliance.

Robert excels in addressing regulatory challenges and implementing lean and compliant solutions. He has a proven ability to create sustainable revenue pipelines, expand market share, and enhance product quality while maximizing operating margin and net income delivery.

As a leader, Robert focuses on team development and innovation, inspiring engaged and high-performing teams to achieve organizational goals. He drives continuous improvement initiatives and collaborates with key stakeholders to develop and deploy policies, processes, and procedures that drive sustainability, quality, and service improvements across the board.

Mark Mews leads the operations and supply chain for the Peripheral Business Group and has been at W.L. Gore and Associates, Inc. for over 16 years spending a majority of that time leading cross-functionally in various operations & supply chain leadership roles across both new product development and commercial life cycles. Mark is an advocate for continuous improvement, creating a lean culture, and focusing teams and organizations on delivering targets that improve both top and bottom-line growth.

Michael Ingles is Edwards Lifesciences Director of Business Excellence, orchestrating the global Operational Maturity Index (OMI) program. He leads an international team of experts assessing business areas across various manufacturing sites to ensure standardization and continuous improvement.

Michael also owns the Edwards Production System (EPS), providing plants with standardized work processes built upon proven principles, practices, and tools. His leadership is pivotal in maintaining world-class standards across the company’s global operations, including facilities in Singapore, Ireland, the Dominican Republic, Puerto Rico, Costa Rica, Utah, Irvine, California, and upcoming plants.

Mike joined Edwards Lifesciences in 2006, working in various roles in finance, project management, and strategy.