Mac McKeen Email & Phone Number
Adjunct Professor @ University of Minnesota College of Science and Engineering
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Mac McKeen Location
- Saint Paul, MN, US
Mac McKeen Work
- 2025 -now Board Member @
- 2023 -now Board Member @
- 2009 -now Adjunct Professor @
- 2011 -2024 Fellow, Regulatory Science - RETIRED @
- 2023 -2024 Partnership Adjunct Faculty at LaSalle University @ Pathway for Patient Health
- 2018 -2023 Member of the Graduate Faculty for TLI’s Master of Science in Medical Device Innovation @ Technological Leadership Institute - University of Minnesota
- 2010 -2021 Faculty Director - Manufacturing Operations Management @
- 2009 -2014 Principal Consultant @ MAC Consulting, LLC
- 2010 -2011 Director Quality Systems and Regulatory Affairs @
- 2005 -2009 Director Regulatory Management @
- 2004 -2005 Director Regulatory Affairs and Compliance @
- 2002 -2004 Regulatory Affairs Manager @
- now Sr. Regulatory Specialist @ Guidant Corporation
- now Corporate Compliance Auditor @
- now Purchasing Manager @
- now Project Buyer @
- now Manufacturing Engineer @
Mac McKeen Education
- The University of Dallas
MBA (NAPM CPM certification)
1984-1987 - Iowa State University
BS (Society of Manufacturing Engineers (SME))
1979-1983
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 Adjunct Professor at University of Minnesota College of Science and Engineering. Mac McKeen brings experience from previous roles at Woodbury Community Foundation, Regulatory Affairs Professionals Society (RAPS), Boston Scientific and Pathway for Patient Health. Mac McKeen holds a 1984 - 1987 MBA in NAPM CPM certification @ 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 3 emails and 1 mobile phone numbers on RocketReach.
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