ASQ Phoenix Section Program Meeting 555
ASQ Phoenix Section Program Meeting
July 11, 2019  6:00pm-8:00pm

SPEAKER: James A. Steele Jr (Vice President of Quality Assurance and Compliance), Watershed Idea Foundry, Inc

TITLE: The Use of Statistical Techniques in Developing Optimized Additive Manufacturing Processes for Producing Ti64 Medical Devices

BIO:  Jim’s focus for over 35 years has been on international manufacturing for companies such as Stryker, Medtronic, Motorola, DEC and General Dynamics. His technical experience includes additive manufacturing, medical device, semiconductors, electronics and aerospace. Led reliability/quality assurance, product/process design & development, manufacturing engineering and operations organizations. After 5 years in consulting, Jim joined Watershed in 2017, to lead their QA and manufacturing design consulting services, implement the company’s Quality Management System and characterize/validate their contract additive manufacturing services. Accomplishments include:
  • Implemented robust design control, risk management and quality management systems for international and client companies
  • Managed 100+ product and process characterizations/validations


  • M.S. Materials Science – University of Wisconsin-Madison
  • B.S. Mechanical Engineering – San Diego State University
  • Graduate Certificate in Regulatory Affairs – University of South Florida

ABSTRACT: The proper use of statistical techniques results in more efficient and effective transformations from research and development into validated processes and finished medical devices ready for released manufacturing. A wide variety of statistical tools were used across the various Design Control (DC) Phases to establish an Additive Manufacturing (AM) process for fabricating Ti64 spinal implants using two different sized 3D printers. The use of simple test vehicles to more sophisticated and sensitive test vehicles throughout the DC Phases, along with the establishment of released AM process monitors is discussed. Screening Design, Partial Factorial and Full Factorial Design of Experiments with Center Points were used to assess process variation and curvature, along with developing several highly predictive Multiple Linear Regression Response Models based on significant slicing software and machine setting factors and their interactions. Single Factor Predictive Models were developed using both linear and nonlinear regression techniques. These techniques were used to maximize predicted model Coefficients of Determination, assess the AM Energy Density model and to generate predictive micro- and macro-porosity transformation equations. The use of Paired t-Tests (for normal distributions) and One Sample Sign Test (for nonparametric distributions) is shared for assessing 3D printing and secondary processing. Studies include whether Hot Isostatic Pressing (HIP) significantly reduces internal porosity in a predicable manner resulting in high density Ti64 product along with the impact of three additive manufacturing zones (edge, hatch and stitch) on pre- and post-HIP porosity.

Date & Time
Thursday July 11th, 2019 8:00pm CDT
End Date & Time
Thursday July 11th, 2019 10:00pm CDT
Edward Jones Training Facility
Edward Jones Training Facility
8333 S River Parkway
Tempe, AZ 85284
United States
Host Type
Webinar Link / Meeting Instructions

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Category Public Calendar