Marnie Smith

I am a Mechanical Engineer by degree that has spent the last 16 years in the medical device industry. I have worked with baby incubators, health monitoring equipment in the home, in vitro diagnostic devices for disease detection, heart pumps, oxygenators, and cannulas with companies such as GE Healthcare, Covidien, Medtronic, and LivaNova. I got started as an Installed Base Engineer that did design changes on existing products that were either in the field or actively being sold to new customers. This included changes because of customer complaints, part obsolescence, or opportunities to make a product better for less. From there, I grew into a Project Manager role that took on bigger projects with a focus on simplifying how the products were made and working with suppliers to find the best fit for manufacturing of the critical components. Along this journey, I had an opportunity to join the Internal Audit team. The medical device industry is heavily regulated which can result with many company specific procedures and requirements that can seem overwhelming and burdensome. It was through this Internal Audit experience that I had a better understanding of why the industry regulations and standards were so important and became really interested in how to do this better. Quality Systems and Quality Engineering can be pretty dry and is perceived in a very black and white perspective. However, I really identified with process improvement opportunities and how to make decisions in the gray. Since then, I have had roles in Supplier Quality, Quality Systems Management, Manager of the Quality Engineering and Validation team, as a Director of Quality Engineering and, currently, Senior Director of Quality for a medical devices professional services organization. Along the way, I’ve done my best to adopt the best practices I’ve seen and developed to new companies I have becoming a part of. I’ve been responsible for leading the implementation and adoption of design controls and all design, process, analytical and clinical validation activities, per the site’s Quality System procedures, for all medical device product development programs at my business. I’m always looking for a way how to make the procedures and processes better in order to make better product to improve peoples lives.