Eric Mckee, Msbme, Mba, Pmp Email and Phone Number
Eric Mckee, Msbme, Mba, Pmp work email
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Eric Mckee, Msbme, Mba, Pmp personal email
As a dedicated Medical Device Product Development Project Manager, I specialize in guiding medical device companies through the complex landscape of medical device product development. With experience leading international teams, I am adept at navigating cultural differences and ensuring seamless collaboration. My expertise lies in streamlining processes, managing teams effectively, and ensuring timely, regulatory-compliant product launches. By focusing on strategic problem-solving and client collaboration, I help bring innovative medical devices to market, improving patient outcomes.Contact me at eric.mckee@cintegratechnology.comHighlights of Expertise • Project Leadership: Successfully led product development teams from concept to market, ensuring projects were completed on time, and within budget. • Outcome-Focused Management: Demonstrated skills in adapting to evolving project requirements, planning, organizing teamwork, and addressing complex technical and logistical challenges to deliver tangible results. • Ensuring regulatory compliance: Consistent focus on regulatory compliance and delivery, reducing potential roadblocks and accelerating product timelines. • Technical Expertise: Proficient in discussing, understanding, and making decisions across various engineering disciplines, ensuring the development of high-quality, reliable products. • Strategic Decision-Making: Possess the managerial courage to manage risks and make impactful decisions that drive project success and align with client goals.Let's connect to discuss how I can help drive your next project to completion.
Cintegra Technology, Inc.
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Principal ConsultantCintegra Technology, Inc. 2002 - PresentCedar, Minnesota, UsDriving innovation from concept to commercialization, I specialize in leading medical product development initiatives. By leveraging my expertise in project management, regulatory compliance, and quality assurance, I guide cross-functional teams to transform company ideas into successful, market-ready products. Project Manager • Directed an international team located across multiple countries to develop a novel cancer detection device. • Led product development teams to develop innovative medical devices, including intrathoracic pressure regulator and pneumatic compression device. • Drives regulatory compliance with FDA QSR and international standards (e.g., IEC 60601-1, IEC 62304, IEC 62366-1) throughout the entire product development lifecycle. • Resolved complex technical challenges, including hardware/software integration, verification test planning, and execution, to ensure product reliability and performance. • Facilitated cross-functional collaboration to ensure seamless product development and timely market launch. • Spearheaded successful third-party testing initiatives for medical devices, ensuring compliance with stringent IEC 62304, IEC 62366-1, and IEC 60601-1 safety standards. "I find Eric focused, competent, and pleasant to work with." VP Research & Development.
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Vice-President EngineeringNextern, Inc. (Mfg Solutions, Inc.) 2006 - 2010An international manufacturing services provider utilizing proprietary production management technology to deliver economical mechanical and electro-mechanical parts and products. Started and led multi-disciplinary product development engineering group assisting clients with new product development for the consumer and medical markets. The team included Asian members for developing products for overseas manufacturing. -
PresidentTactile Systems Technology, Inc 2000 - 2004Minneapolis, Minnesota, UsMedical device company dedicated to advancing the standard of care in treating edema and vascular diseases. Developed market leading innovative new product that changed the standard of care for at-home treatment of lymphedema and chronic wounds. Lead effort to take the Class II device from product concept to FDA marketing clearance approval for less than $250,000 (an unprecedented amount).Development included instituting a FDA approved quality system; designing product mechanical hardware, electronics, and software; navigating national & international agency testing requirements for medical products; creating FDA 510(k) application; receiving FDA marketing clearance; awarding of multiple patents; establishing manufacturing; and beginning product sales.
Eric Mckee, Msbme, Mba, Pmp Skills
Eric Mckee, Msbme, Mba, Pmp Education Details
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University Of California, DavisBiomedical Engineering -
University Of California, Davis - Graduate School Of ManagementBusiness Administration
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University Of Evansville, InElectrical Engineering
Frequently Asked Questions about Eric Mckee, Msbme, Mba, Pmp
What company does Eric Mckee, Msbme, Mba, Pmp work for?
Eric Mckee, Msbme, Mba, Pmp works for Cintegra Technology, Inc.
What is Eric Mckee, Msbme, Mba, Pmp's role at the current company?
Eric Mckee, Msbme, Mba, Pmp's current role is Technical Project Manager for Medical Device Product Development Teams | Leader of Cross-Functional, Cross-Cultural Teams | Results-Oriented | Servant Leader.
What is Eric Mckee, Msbme, Mba, Pmp's email address?
Eric Mckee, Msbme, Mba, Pmp's email address is er****@****ogy.com
What schools did Eric Mckee, Msbme, Mba, Pmp attend?
Eric Mckee, Msbme, Mba, Pmp attended University Of California, Davis, University Of California, Davis - Graduate School Of Management, University Of Evansville, In.
What skills is Eric Mckee, Msbme, Mba, Pmp known for?
Eric Mckee, Msbme, Mba, Pmp has skills like Embedded Systems, Product Development, Electronics, Manufacturing, Medical Devices, Leadership, Start Ups, Project Management, Engineering, Firmware, Embedded Software, Electrical Engineering.
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