Location New Hartford, Connecticut, United States Regions East Coast, New England, Northeastern US Gender Female
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Jayme Coates MS, MBA has been in the medical device industry for the past fifteen plus years. To date, she has led the design and development of more than 100 unique medical devices, including concept development, design, verification testing, and prototype manufacturing, primarily in the Class III active implantable space. Her skills include: U.S.
Food and Drug Administration (FDA) compliance; Project Management; Verification and Validation (V&V); Medical Devices; Biomedical Engineering; ISO 13485; Active Implantable Devices; and Product Development. On the academic side, she worked in the biodynamics lab at the University of Connecticut as a research assistant, and completed her Master’s thesis on sensor technologies and modalities. Jayme received her MBA (UCONN) in 2010 and was the general manager of a contract manufacturing firm responsible for over $30M revenue and over 200 employees. Since then she has successfully founded an engineering consulting firm called The Luxi Group that helps start-ups and mid-sized medical device companies with product development from the technical and project management and operational aspects. Of all her extensive background and experience, it was her own breastfeeding journey with her newborn that brought her to the Manoula device.
