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Specialties: Electrochemistry and PlatingProcess EngineeringIn-vitro/vivo testingMaterial ScienceFDA Regulations or biomedial devicesCell Operating SystemLean Six SigmaLine balancingCapacity ModelingNew Product IntroductionLine TransferSupplier ManagementFDA/OUS SubmissionsProcess ValidationsSustaining EngineeringCAPA Management
Medtronic Diabetes
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Senior Director Of Advanced Manufacturing Engineering, OperationsMedtronic Diabetes Jul 2024 - Present
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Director Of Advanced Manufacturing Engineering, OperationsMedtronic Diabetes Apr 2017 - Jul 2024Align the efforts of cross-functional manufacturing, quality, regulatory, administrative, and engineering teams to successfully manage a $550M value stream. • Author a complex, comprehensive manufacturing capacity model aimed at line balancing. Improve capacity and output to successfully launch Guardian Sensor 3 hybrid closed loop system. • Target continuous improvement projects that increase labor efficiency and scrap reduction.• Design and validate ISO cleanrooms and actively prepare for and participate in regulatory audits. Pass audits with zero non-conformances/findings.
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Senior Engineering Manager, Glucose Sensor OperationsMedtronic Diabetes 2013 - 2016Actively participated in the transfer of operations and launch of a new product in the Puerto Rico facility. Focused heavily on continuous improvement, engineering team development, and product management. • Seamlessly transferred the manufacturing product line to the Puerto Rico facility. Increased efficiency and reduced scrap.• Stretched financial targets, goals, and objectives through new continuous improvement projects. Enhanced revenue performance.• Sourced, hired, and trained new engineering staff, growing the overall headcount.
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Engineering Manager, Glucose Sensor OperationsMedtronic Diabetes 2011 - 2013Regularly engaged the engineering team during the fabrication of new glucose sensors. Pioneered the launch of the Enlite Glucose Sensor in OUS geographies. • Allowed the business to exceed forecasted revenue targets after the successful international launch of the Enlite Glucose Sensor product.
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Engineering Supervisor, Glucose Sensor R&DMedtronic Diabetes 2008 - 2011Explored research and development opportunities for glucose sensors in medical products. Collaborated with several cross-functional teams during the development of innovative new products.• Constructed trial periods into the consumer market by creatively deploying marketing and branding initiatives. Tested the product to ensure sustainability and growth in the market.• Successfully launched the Veo Sensor OUS with record profitability and market penetration results. Drastically increased the effectiveness of brand goals/objectives.• Ensured newly launched products complied with all regulatory, quality, and other company requirements. Enhanced the end customer satisfaction and experience with the product.
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Research Scientist, Glucose Sensor R&DMedtronic Diabetes 2006 - 2008
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Senior Clinical Specialist, Clinical ResearchMedtronic Diabetes 2005 - 2006
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Clinical Research AssociateMedtronic Diabetes 2002 - 2005
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Clinical TechnicianMedtronic Diabetes 2000 - 2002
Ken Cooper Skills
Ken Cooper Education Details
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California State University, FullertonCriminal Justice -
California State University, StanislausCriminal Justice
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College Of The CanyonsGeneral Education
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Canyon High SchoolGeneral Studies
Frequently Asked Questions about Ken Cooper
What company does Ken Cooper work for?
Ken Cooper works for Medtronic Diabetes
What is Ken Cooper's role at the current company?
Ken Cooper's current role is Advanced Manufacturing Engineering Professional.
What is Ken Cooper's email address?
Ken Cooper's email address is ke****@****nic.com
What is Ken Cooper's direct phone number?
Ken Cooper's direct phone number is +181868*****
What schools did Ken Cooper attend?
Ken Cooper attended California State University, Fullerton, California State University, Stanislaus, College Of The Canyons, Canyon High School.
What skills is Ken Cooper known for?
Ken Cooper has skills like Fda, Medical Devices, Process Engineering, Cross Functional Team Leadership, Biomedical Engineering, Complex Engineering Operations, Financial Performance Monitoring, Iso 13485, Testing, Materials Science, R&d, Biotechnology.
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