1. Douglas Breitenfeld
4806 South Elk Way Aurora, CO 80016 303.990.4931 doug.breitenfeld@live.com
Objective
To improve Patient Care and Safety by growing upon my 16 years of product design,
development and manufacturing background.
Education
University of Colorado at Denver, 1993-1997
Bachelor of Science in Mechanical Engineering
Metropolitan State College of Denver, 1992-1993
General Studies
Experience
CareFusion – Englewood, CO
Principle Engineer – Mechanical, January 2014 to Present
Responsible for the day-to-day product maintenance over all product lines manufactured at
the Englewood, CO facility.
Approve design changes as member of the Engineering Change Control Board. Evaluate
and disposition nonconforming materials as member of the Material Review Board.
Function as technical support for Manufacturing Engineering, Production, Purchasing,
Quality, Regulatory, Marketing and Sales departments.
Working with multi-site teams to transfer manufacturing and technology from Totowa, NJ
and Englewood, CO facilities to CareFusion Mexicali, MX facility.
Managed site level project to add country specific package labeling to GE Korea OEM
products that would result in approximately $40,000/year savings for GE Korea.
GE Healthcare – Englewood, CO
R & D Engineer, November 2008 to December 2013
Responsible for the day-to-day product maintenance over all product lines manufactured at
the Englewood, CO facility.
Approve design changes as member of the Engineering Change Control Board. Evaluate
and disposition nonconforming materials as member of the Material Review Board.
Acted as engineering SME for internal quality audits, Notified Body audits (KEMA and
TUV) and FDA Inspection
Managed programs to evaluate and prove RoHS compliance (2002/95/EC and
2011/65/EU) and IEC 60601 3rd edition compliance for the laryngoscope handle lines.
Created and maintained product Risk Management files per ISO 14971 requirements.
Conducted product complaint investigations including Root Cause Analysis and Risk
Assessments for site manufactured product.
Worked with international team in Helsinki Finland on various Product Development and
Design for Manufacturability projects.
Vital Signs, Inc. – Englewood, CO
Engineer I, 2001 to October 2008
2. Douglas Breitenfeld
4806 South Elk Way Aurora, CO 80016 303.990.4931 doug.breitenfeld@live.com
Member of site Engineering team that developed multiple New Product Introductions
including: GreenLight II™ and Vital View II™ reusable LED laryngoscope handles,
SteeLite™ disposable laryngoscope blades, iMask™ Nasal CPAP mask, Aeromask™ low
cost oxygen/nebulization mask, C-CO2™ colorimetric indicator.
Transferred Actar D-Fib™ CPR mannequin and Actar AED Trainer™ production in-house.
Manufactured and tested prototype designs.
Utilized Rapid Prototyping manufacturing processes to speed product release to market.
Worked with Maintenance and Engineering Technician teams to develop and reverse
engineer production automated assembly equipment componentry for the purposes of
increasing productivity, reducing production down-time, and reducing repair costs.
Creation and maintenance of site level Standard Operating Procedures, Operating
Instructions, controlled forms, product labeling (product labels, inserts, instructions for use
printed bags and foils), product, packaging, manufacturing and assembly specifications.
Draftsman, February 1999 to 2001
Converted legacy purchasing, manufacturing and production assembly drawings from
paper based and 2D digitized (PRIME Medusa) drawings to Pro Engineer 3D
Processed drawing changes through Engineering change process.
Proficiencies
Design for:
Plastic injection molding, Over Molding, Plastic Extrusion, Vacuum Corrugation, Metal Die
Stamping, Milling and Turning, Investment Casting, Wire Bending, EN Plating, TiN PVD
Coating, Anodizing, Passivating, Laser Etching
Computer Aided Design:
Pro Engineer (R18 - Wildfire 5), SolidWorks (2013 - 2014), Prime MEDUSA
Office Software:
Word, Excel, Power Point, Project, Adobe Acrobat Professional
Enterprise Resource Planning and Product Lifecycle/ Product Data Management:
Agile, Oracle, JD Edwards, GE MyWorkshop
Other Software:
TrackWise complaint handling, IBM Rational DOORS requirements management
Inspection equipment:
Pin, plug and ring gages, gage blocks, calipers, micrometers, indicators, optical comparators,
Vision systems.
Manufacturing equipment:
Basic hand tools, drills hand and upright, grinders, sanders, saws (band, jig, circular), basic
milling and lathe turning, MIG Welding
Hobbies
Automotive restoration, big game hunting, fishing, landscaping, travel