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Mike Hoffa Location
Brownsburg, IN, US
Mike Hoffa Work
2023 -now COO @
2013 -now President and Owner @ Momentum Medical Consultants
2022 -2023 Chief Compliance Officer @
2016 -2022 Chief Operations Officer @
2015 -2016 Associate Engineering Advisor @ Eli Lilly and Company
2010 -2013 Vice President - Product Development and Technical Service @
2008 -2010 Senior Director - Product Development and Technical Service @
2004 -2008 Director - Product Development @ Suros Surgical Systems / Hologic
1992 -2004 Product Development Manager @
1990 -1992 Process Improvement Engineer @
Mike Hoffa Education
Indiana University - Kelley School of Business
Executive Certificate in the Business of Life Sciences
2014-2015
Purdue University
Six Sigma Black Belt
2014-2014
Stat-a-matrix
ISO 13485 (2003) QMS Lead Auditor Training
Rose-Hulman Institute of Technology
Mike Hoffa Skills
• Rapid to market product development experience
• Creation and management of effective and talented teams
• Broad understanding of the medical device industry
• Ability to quickly understand complex problems and create simple and actionabl
• Extensive experience in angioplasty catheters, balloon expandable stents and b
Medical Devices
Start-ups
R&D
Design Control
ISO
V&V
Product Development
Design for Manufacturing
Leadership
Market Development
ISO 13485
Manufacturing
FDA
Quality System
CAPA
Lean Manufacturing
FMEA
Quality Assurance
Strategy
Continuous Improvement
Biomedical Engineering
Design of Experiments
Regulatory Affairs
Capital Equipment
Product Launch
Validation
Cross-functional Team Leadership
Injection Molding
Commercialization
Manufacturing Operations
Product Management
GMP
Project Management
Cross Functional Team Leadership
ISO Standards
Broad Understanding of the Medical Device Industry
Testing
Extensive Experience in Angioplasty Catheters
Disposables
Creation and Management of Effective and Talented Teams
Biotechnology
Start Ups
Rapid to Market Product Development Experience
Research
Balloon Expandable Stents and B
Marketing
Mike Hoffa Summary
Mike Hoffa, based in Brownsburg, IN, US, is currently a COO at GeniPhys, Inc.. Mike Hoffa brings experience from previous roles at Momentum Medical Consultants, Probo Medical and Eli Lilly and Company. Mike Hoffa holds a 2014 - 2015 Executive Certificate in the Business of Life Sciences @ Indiana University - Kelley School of Business. With a robust skill set that includes • Rapid to market product development experience, • Creation and management of effective and talented teams, • Broad understanding of the medical device industry, • Ability to quickly understand complex problems and create simple and actionabl, • Extensive experience in angioplasty catheters, balloon expandable stents and b and more. Mike Hoffa has 3 emails and 2 mobile phone numbers on RocketReach.
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