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Faculty: José Mora ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD3357


  • Date:1/26/2023 11:00 AM - 1/26/2023 12:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event

Description

The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum.

NOTE: This webinar does not focuses on statistical methods, analysis of variance, and other techniques, but rather focuses on DOE strategies and the overall approach for successful DOE’s.

Learning Objectives:

  • Effective DOE strategies
  • Avoiding pitfalls when performing DOEs
  • How to capture the essence of a process
  • Using the right resolution at the right time
  • Use of DOEs during process validation
  • How to prevent “expert” bias when designing experiments.
  • Letting the process do the talking.
  • “Poke the Alligator” – see how the process reacts

Areas Covered in the Session :

  • Gauge R&R considerations.
  • Screening DOEs
  • Mapping DOEs
  • Robust Process DOEs
  • Use of Six Sigma DMAIC when using DOEs and vice versa
  • Obtaining proper input from various stakeholders
  • Use of DOEs during process validation

Who Should Attend:

  • Senior and middle management
  • Quality Assurance
  • Research and Development
  • Manufacturing
  • Production
  • Engineering
  • Design Engineers
  • Design Assurance

Course Director: JOSÉ MORA

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’’s leadership.

He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.