Orlando Guillory serves as a Senior Distinguished Engineer at Edwards Lifesciences, where he leverages over two decades of extensive experience in the medical device industry to drive innovation and excellence in product development. His role is pivotal in establishing cutting-edge, value-added processes and procedures that...
Orlando Guillory serves as a Senior Distinguished Engineer at Edwards Lifesciences, where he leverages over two decades of extensive experience in the medical device industry to drive innovation and excellence in product development. His role is pivotal in establishing cutting-edge, value-added processes and procedures that not only advance technologies but also simplify and standardize the new product development lifecycle across various manufacturing sites. With a deep understanding of Class II and III medical devices, Orlando excels in areas such as design control, risk management in accordance with ISO 14971, and the creation of essential documentation like Design History Files (DHF) and Device Master Records (DMR).
Orlando's expertise extends to manufacturing operations management, where he applies his skills in problem-solving and decision-making to enhance operational efficiency. He is instrumental in training and mentoring teams across multiple engineering disciplines, focusing on new product development and quality systems. His commitment to fostering a culture of continuous improvement is evident in his hands-on approach to post-market surveillance and Corrective and Preventive Actions (CAPA), ensuring that products not only meet regulatory standards set by the FDA but also exceed quality expectations.
Key projects under Orlando's leadership have included the integration of advanced manufacturing techniques such as anodizing and aluminum extrusion, which have significantly improved product durability and performance. His strategic vision and collaborative spirit enable him to work seamlessly across engineering, development, and site operations, making him a vital asset to Edwards Lifesciences as they continue to innovate and lead in the medical device sector.
