Eric Mckee, Msbme, Mba, Pmp Email & Phone Number

Cedar, Minnesota, Us

Driving 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.

An 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.

Minneapolis, Minnesota, Us

Medical 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.

Master'S, Biomedical Engineering

Master'S, Business Administration

Bachelors, Electrical Engineering