Engineer Manufacturing
Resume:
Shawn Dalton
Round Rock, TX 78664
*****.*********@*****.***
Experienced Engineer Skilled in:
Lean Six Sigma Project Management
Implementation
ISO 14971/Risk Management Process Development
FDA 820 Compliance DMAIC/FMEA/DOE
EXPERIENCE
January 2008 to May 2011
Zimmer Spine (Formerly Abbott Spine)
Senior Quality Engineer I
Post Surveillance Group
Perform complaint investigations to determine root cause of instrument and
implant alleged deficiencies for spinal fixation/fusion product.
Use statistical methods during investigations to determine quality trends
that may require further action such as Risk Evaluations and CAPA
investigations.
Create Cognos reports to ensure that compliance is met on complaint parts
being received back from distribution agencies. Reports reduced workload of
compliance requirements by 90%.
Work with design groups to integrate post surveillance product information
into new products.
Use FMEA to analyze new and existing products to determine potential
failure modes and their affects, especially failure modes that could cause
injury or death.
Participate in CAPA teams to perform root cause analysis of alleged
deficiencies.
Participate in Risk Evaluation teams to determine overall heath risk of
instrument and implant complaint events.
Submit Medical Device Reports to the FDA for reportable complaint events.
Mine and present past complaint event data for 510K product applications to
FDA.
July 2005 - December 2007
Boston Scientific (Formerly Guidant)
Senior Quality Engineer
Brady Pacemaker Manufacturing
Supported circuit board manufacturing and resolved quality issues
encountered on a daily basis.
Headed Lean Six Sigma project teams to increase quality, reduce product
cost and increase manufacturing efficiency.
Created FMEAs for product and processes to determine potential failure
modes.
Employed design of experiments methodology to increase quality levels in
the manufacturing processes.
Analyzed and resolved all compliance issues in manufacturing of
pacemaker/defib circuit boards.
Performed peer reviews with manufacturing in order to resolve quality
concerns.
Implemented Infinity QS process control system which reduced entry and
analysis of control charts by 40%.
January 2003 - July 2005
Boston Scientific (Formerly Guidant)
Senior R&D Mechanical Engineer
Defibrillator Capacitor Development
Participated in 510K FDA submission teams for Class III medical products.
Developed new processes and equipment for high voltage capacitor
manufacturing.
Wrote IQ, OQ, PQ protocols for new processes and equipment.
Performed PQ validations on new capacitor manufacturing products and
processes.
Designed and implemented new capacitor foil pick head that increased new
capacitor product yield from 1% to 99%
Coordinated external vendor activities to adapt existing laser
interferometer leak tester to Guidant capacitor product. Optical leak
tester tested ten times more products with 5 time's higher accuracy than
existing leak test technologies available.
Coordinated vendor activities to replace existing filling technology used
in capacitor manufacturing. Developed equipment that eliminated 99% of
electrolyte waste, reduced cleaning of capacitor product by 80%, and
reduced cycle time by 20%.
December 1999 - January 2003
ADC Telecommunications
Senior Manufacturing Engineer
Project managed transaction of products from design to manufacturing.
Responsibilities included:
Coordination of design to external vendor builds.
Creation and scheduling of training required for operators in Mexico.
Purchase and transfer of required tooling for manufacturing
operations.
Submit budget proposals for acquisition of tooling and equipment.
Project managed tasks required to implement prototype development
line
Selection and purchase of circuit board assembly equipment Coordination of
facilities group tasks, external and internal Purchase of and transfer of
required tooling for manufacturing operation.
Project managed team to reduce automated machine placement equipment setup
reduction. Setup reduction effort resulted in a 600% reduction in setup
time.
Implemented prototype surface mount technology line which enabled
prototypes to be built in 80% less time than outside suppliers.
Developed processes for new products, eliminated need for outside
manufacturing support.
1996-1999
Harris - Microwave Communications Division
Product Engineer II
Project leader during implementation of Unicam Computer Integrated
Manufacturing Software. Programming time required for automated equipment
reduced from 3 hours to 8 minutes.
Supported the manufacture of new products and prototypes resulting in 20%
quicker lead times than externally built product.
Developed and maintained all manufacturing processes in the PCB area - SMT
Placement, Reflow, Wave Soldering, Secondary Processes, Hand Soldering, and
Hot Gas Rework Stations.
Implemented statistical process control into S.M.T. line processes, screen
printing, component placement, and reflow. Manufacturing defects in
production were reduced by 50%
1993-1996
AMP
Manufacturing Engineer I
Project managed tasks required to transition products from design to
manufacturing.
Responsibilities included:
Coordination of design to external vendor builds.
Creation and scheduling of training required for operators in Mexico.
Purchase and transfer of tooling for manufacturing operation to
Mexico.
1992 - 1993
Motorola Automotive and Industrial Electronics Group
New Product Process Engineer
Lowered screen-printing defects level by half by designing and performing
design of experiments to optimize parameters.
Led plant wide Screen Printing Development Team that focused on methods to
standardize operating parameters and defect measurement procedures for
screen printing, reflow, and wave-soldering processes.
Eliminated labor and equipment costs required of post-soldering methods by
developing specialized thermal profiles to achieve through-hole reflow for
Fr4 and polyimide circuit boards.
EDUCATION: B.S., Mechanical Engineering, University of Texas.
TRAINING: Six Sigma Greenbelt Certification, Project Management Institute
(PMI) Training, DMAIC Process training
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