David W Wu

About David W Wu

Experienced engineer with a strong engineering and project management background. Expert in data analysis, design control, process validation, reliability engineering, troubleshooting, and training. Led and managed project teams for quality system development, risk management, product design, and process improvement. Recognized leader with experience working with marketing, product development, regulatory, manufacturing, suppliers, and customers to develop products from concept to commercialization.

Experience

1. Senior Design Quality Engineer

   Spacelabs

   Apr 2018 — Present · Snoqualmie, WA, US

   Lead design quality effort for software driven electronic medical device design, development, and reliability• Provide direction to cross-functional teams in the areas of design control, product quality, and risk management• Guide teams on new product and process validation/verification, process capability, design transfer, and DHF• Coach Engineering, Quality, and Manufacturing on design of experiments (DOE), comparative analysis, correlation studies, and continuous improvements• Mentor and influence Product Development teams using best practices, balancing priorities and resources• Apply reliability engineering to patient monitoring, anesthesia, and diagnostic cardiology devices• Lead the design transfer development effort to promote design for manufacturing, assembly, testing, inspection, and service• Coach young engineers on quality control to ensure developed products are safe, effective, and compliant• Train contractors on quality system, design control, change control, and CAPA• Lead international audit response to address quality gap and take corrective and preventive actions for issues• Improve project review process by rewriting design phase review procedure

Education

• University of Tennessee, Knoxville

  Master of Science in Statistics

• Wuhan Industrial Institute

  Bachelor of Science in Engineering

• University of Tennessee, Knoxville

  Master of Science in Textile Polymer Engineering

Skills

• Risk Analysis
• Medical Devices
• Msa
• Failure Mode and Effects Analysis (Fmea)
• Design for Assembly
• Quality Control
• Inspection
• Corrective and Preventive Action (Capa)
• Regression Analysis
• Quality Assurance
• Change Control
• Statistics
• Design Control
• Iso 14971
• Cgmp Practices
• Verification and Validation (V&V)
• Change Impact Analysis
• Quality System
• Production Part Approval Process (Ppap)
• Computer-Aided Design (Cad)
• Research and Development (R&D)
• Premarket Approval (Pma)
• Statistical Process Control (Spc)
• Machining
• Advanced Product Quality Planning (Apqp)
• Gages
• Gmp
• Reliability Engineering
• Manufacturing
• Feasibility Studies
• Process Validation
• Business Development
• U.s. Food and Drug Administration (Fda)
• Iso 13485
• Project Management
• Design for Manufacturing
• Quality Auditing
• Cross-Functional Team Leadership
• Design of Experiments
• Test Automation