Product Dev. Excellence Consulting

 

Increasing Compliance to Design Controls and Improving Product Development Efficiency

  
 

Résumé

Summary    

Multi-discipline hands-on R&D leader with over twenty years of experience in medical device product development and manufacturing with expertise in electronic, optical, software, mechanical, video and pneumatic systems. Proven skills building and leading teams, analyzing and resolving problems, meeting challenging goals and educating across the organization. Committed to customer quality, regulatory compliance and doing the right thing. Expertise in FDA 21 CFR Part 820 QSR, ISO 13485, ISO 14971, Product Development Processes, Design for Six Sigma and Lean.

  
Past Experience    
Nellcor (Covidien) - Pleasanton, CA
Director of Operational Excellence 	2006-2007
Test Engineering Manager 		1994-2006
 
Stryker Endoscopy - San Jose, CA
Development Engineering Manager	1991-1993
 
Leica, Inc - Buffalo, NY
Development Engineer			1987-1991
Manufacturing Engineer			1985-1987
 

Contact information  :

 
Chuck White
pde@ chuckwhite. com

 
© 2008 Product Dev. Excellence
updated 2/56/08