Terry Irwin Email & Phone Number
Sr. Distinguished Engineer @ Edwards Lifesciences
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Terry Irwin Location
- Mission Viejo, CA, US
Terry Irwin Work
- Sr. Distinguished Engineer @ (January 2020 - Present)
- Sr Manager of Quality, Advanced Technology @ (January 2017 - December 2019)
- Director of Quality - Site Quality Lead @ (April 2013 - February 2017)
- Quality Assurance Manager @ (January 2007 - November 2012)
- Senior Quality Engineer @ (February 2004 - January 2007)
- Quality Manager @ (January 2000 - July 2003)
- Lead Engineer and Technical Engineering Manager @ (October 1996 - January 2000)
- Sales Engineer @ (July 1995 - October 1996)
- Sales Engineer and CAD Interface Program Coordinator @ Computer Aided Design Software, Inc. (May 1992 - July 1995)
Terry Irwin Education
- University of St. Thomas - Opus College of Business
MBA (Business)
2005-2008 - University of Iowa
Bachelor of Science (Mechanical Engineering)
1988-1992
Terry Irwin Skills
- FDA Regulatory Compliance
- Equipment IQ/OQ/PQ
- Software Validation
- ISO 14001
- ISO 13485
- ISO 9001
- EN 46001
- Medical Devices
- Standards Compliance
- Quality Auditing
- Product Design and Development
- Statistics
- Design of Experiments
- Lean Sigma
- Green Belt
- Value Stream Mapping
- Quality Management
- Quality by Design
- CAD/CAM/CAE
- Risk Management
- Organizational Development
- Organizational Leadership
- Sterilization Validation and Monitoring
- Test Methodologies
- Test Planning
- User Acceptance Testing
- Data Analysis
- Budget Management
- Capital Budgeting
- Equipment Design
- Supplier Quality and Auditing
- Project Planning and Execution
- Direct Sales
- MBA
- Mechanical Engineering
- Calibration and Metrology
- Regulatory Submissions
- Strategic Planning
- SWOT analysis
- FMEA
- Quality Assurance and Engineering
- Clean Room Validation
- Construction
- Measurement System Analysis
- Finite Element Analysis
- Software Sales
- 21 CFR
- Six Sigma
- FDA
- Validation
- Quality Engineer
- Manufacturing Engineer
- Manufacturing
- Customer Service
- Project Management
- Technical Engineering
Terry Irwin Summary
- Terry Irwin, based in Mission Viejo, CA, US, is currently a Sr. Distinguished Engineer at Edwards Lifesciences. Terry Irwin brings experience from previous roles at Edwards Lifesciences, NUVAIRA, Inc. and Boston Scientific. Terry Irwin holds a 2005 - 2008 MBA in Business @ University of St. Thomas - Opus College of Business. With a robust skill set that includes FDA Regulatory Compliance, Equipment IQ/OQ/PQ, Software Validation, ISO 14001, ISO 13485 and more. Terry Irwin has 2 emails and 1 mobile phone numbers on RocketReach.
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