Marnie Smith
Mrs Marnie Smith
Manager, Quality Engineering and Validation, Canon Bio-Medical
Rockville, MD

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I am a Mechanical Engineer by degree that has spent the last 13 years in the medical device industry. I have worked with baby incubators, health monitoring equipment in the home, and in development of an in vitro diagnostic device for disease detection with companies such as GE Healthcare, Covidien, Medtronic, and Canon. 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, and, currently, as a Manager of the Quality Engineering and Validation team. 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’m 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.
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Latest Questions
  • Zay Yar Min asked Marnie Smith, Canon Bio-Medical

    Added Saturday, May 5, 2018 at 4:39 AM

    Is there a job which is a combination of engineering and MBA?
    Related to Aeronautical/Aerospace , Architectural, Communications, Education, Graduate School, Internships & Jobs, Machines, Mechanical, Merging Fields, Special fields and Interdisciplinary, Sports & Entertainment
    Answers 1
    Marnie Smith, Canon Bio-Medical
    Answered Tuesday, May 8, 2018 at 4:31 PM
    Hi there! Great news, there are a ton of job options that you can combine a degree in engineering and an MBA with! In fact, I was heavily considering pursuing my MBA last year. I wanted to combine the problem solving abilities I have gained with my ...
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  • Sariha Azad

    Added Wednesday, May 2, 2018 at 12:11 PM

    I am a freshman student of electrical and electronic engineering. My classes have started just a month ago and already I am feeling terribly frustrated. Recently I have messed up badly in a test. Many of my classmates solved the problem correctly in time. I tried the problem at home and after vigorous efforts I solved it. But I won't get my marks back. I have no other option than going on with this. I have always been a bright student and now I am afraid that I'll be a dropout. Please tell me ...
    Answers 1
    Marnie Smith, Canon Bio-Medical
    Answered Thursday, May 3, 2018 at 10:28 PM
    It will be okay! I know it may not feel like that right now, especially if you are used to doing really well. College classes are much more challenging than high school, especially within Engineering. You will still have additional tests in your course ...
    Read More
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