Irwin & Associates - San Jose since Jan 2013
Past President
Irwin and Associates Consulting - San Jose, CA Jan 2012 - Dec 2012
VP Business Development
Irwin and Associates Consulting Mar 1996 - Feb 2012
President
Project Connections Sep 1999 - Dec 2000
Director of Operations
Boston Scientific May 1996 - Sep 1999
Senior Engineer / Project Manager
Education:
San Jose State University 1994
Florida Atlantic University 1983
Skills:
Validation Technical Writing Sop Manuals Test Methodologies Writing Medical Devices Editing Guides Process Validation Documentation Iso 13485 Test Strategy Technical Documentation Software Documentation V&V Commercialization Design Control Regulatory Affairs Quality Assurance Fda Quality System Capa Iso 14971 Injection Molding Design of Experiments R&D Process Simulation Engineering Product Launch Design For Manufacturing Product Development Gmp Technology Transfer