Mac McKeen Email & Phone Number
Consultant to Minnesota DEED - AI Education @ University of Minnesota College of Science and Engineering
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Mac McKeen Location
- Saint Paul, MN, US
Mac McKeen Work
- Consultant to Minnesota DEED - AI Education @ (May 2026 - Present)
- Adjunct Professor @ (January 2009 - Present)
- Board Member @ (June 2025 - Present)
- Board Member @ (August 2023 - Present)
- Fellow, Regulatory Science - RETIRED @ (June 2011 - June 2024)
- Partnership Adjunct Faculty at LaSalle University @ Pathway for Patient Health (January 2023 - January 2024)
- Member of the Graduate Faculty for TLI’s Master of Science in Medical Device Innovation @ Technological Leadership Institute - University of Minnesota (March 2018 - September 2023)
- Faculty Director - Manufacturing Operations Management @ (August 2010 - June 2021)
- Principal Consultant @ MAC Consulting, LLC (December 2009 - April 2014)
- Director Quality Systems and Regulatory Affairs @ (March 2010 - March 2011)
- Director Regulatory Management @ (August 2005 - December 2009)
- Director Regulatory Affairs and Compliance @ (June 2004 - July 2005)
- Regulatory Affairs Manager @ (June 2002 - June 2004)
- Sr. Regulatory Specialist @ Guidant Corporation (January 1996 - January 2002)
- Guidant @ (January 1992 - January 1996)
- Texas Instruments @ 6 yrs 1 mo (January 1983 - January 1989)
Mac McKeen Education
- The University of Dallas
MBA (Contract Administration)
1984-1987 - Iowa State University
BS (Industrial Technology)
1979-1983 - University of Minnesota
Mac McKeen Skills
- Regulatory Strategy
- Project Management
- Collaborative Leadership
- Creative Strategy
- 510 K
- FDA
- Medical Devices
- Quality Systems
- Regulatory Affairs
- Compliance
- Manufacturing
- ISO 13485
- CAPA
- Design Control
- QSR
- Regulatory Submissions
- ISO 14971
- Quality Engineering
- cGMP
- PMA
- GLP
- Product Development
- Biomedical Engineering
- Validations
- Catheters
- Stents
- Pacemakers
- Medical Device Product Development
- CE marking
- Quality System
- Minitab
- Validation
- GMP
- Strategy
- ISO
- Product Launch
- Lifesciences
- Leadership
- V&V
- Commercialization
- R&D
- Design of Experiments
- Quality Auditing
- Quality Control
- Six Sigma
- Start-ups
- Design for Manufacturing
- Program Management
- FMEA
- Process Simulation
- Quality Management
- Root Cause Analysis
- Cross-functional Team Leadership
- Life Sciences
- Purchasing
- Cross Functional Team Leadership
- Medical Device Product
- Public Speaking
- Regulatory
- See 35+see Less
- Cross Functional Team
- Negotiation
- Engineers
- Start Ups
- Customer Service
Mac McKeen Summary
- Mac McKeen, based in Saint Paul, MN, US, is currently a Consultant to Minnesota DEED - AI Education at University of Minnesota College of Science and Engineering. Mac McKeen brings experience from previous roles at University of Minnesota College of Science and Engineering, Woodbury Community Foundation, Regulatory Affairs Professionals Society (RAPS) and Boston Scientific. Mac McKeen holds a 1984 - 1987 MBA in Contract Administration @ The University of Dallas. With a robust skill set that includes Regulatory Strategy, Project Management, Collaborative Leadership, Creative Strategy, 510 K and more. Mac McKeen has 4 emails and 1 mobile phone numbers on RocketReach.
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