David Wu
Senior Design Quality Engineer at SPACELABS | Roswell, Georgia, United States
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David W Wu is a seasoned Senior Design Quality Engineer at SPACELABS, where he plays a pivotal role in ensuring the quality and reliability of software-driven electronic medical devices. With a robust background in engineering and project management, David leads the design quality efforts that are critical to the development of innovative healthcare solutions. His expertise encompasses a wide array of disciplines, including design control, risk management, and process validation, making him an invaluable asset to cross-functional teams.
At SPACELABS, David directs initiatives that focus on new product and process validation, guiding teams through the complexities of design transfer and the maintenance of Design History Files (DHF). His leadership is instrumental in fostering collaboration among marketing, product development, regulatory, and manufacturing teams, ensuring that all aspects of product quality are meticulously addressed. David's proficiency in risk analysis and verification and validation (V&V) processes allows him to effectively identify potential issues early in the design phase, significantly enhancing product reliability and safety.
In addition to his technical skills, David is recognized for his ability to coach and mentor engineering teams, instilling best practices in design control and change management. His hands-on experience with geometric dimensioning and tolerancing, measurement system analysis (MSA), and injection molding further enhances his capability to drive process improvements and deliver high-quality medical devices that meet stringent regulatory standards. David's commitment to excellence and continuous improvement positions him as a leader in the biomedical engineering field, dedicated to advancing healthcare technology through innovative design and quality assurance practices.
Senior Design Quality Engineer at SPACELABS in April 2018 to Present
Senior Quality Engineer at Bioventus in November 2016 to March 2018
Senior Design Quality Engineer at Medtronic Spine & Biologics in January 2009 to November 2016
Design and Engineering at ... in January 1990 to January 2008
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University of Tennessee, Knoxville
University of Tennessee, Knoxville
Wuhan Industrial Institute
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Project Management
Medical Devices
Geometric Dimensioning & Tolerancing
Risk Management
Quality Auditing
Quality System
Quality Management
Quality Control
Advanced Product Quality Planning (APQP)
Quality Improvement
Process Validation
Continuous Improvement
Corrective and Preventive Action (CAPA)
Auditing
Design Control
Change Control
Lean Six Sigma
Change Impact Analysis
Failure Mode and Effects Analysis (FMEA)
ISO 13485
ISO 14971
Risk Analysis
Biomedical Engineering
Reliability Engineering
21 CFR 820
MSA
Computer-Aided Design (CAD)
Product Development
Research and Development (R&D)
Production Part Approval Process (PPAP)
ISO Standards
Feasibility Studies
Statistics
Statistical Process Control (SPC)
Design of Experiments
Gage R&R
Gages
Machining
Lean Manufacturing
Design for Manufacturing
Design for Assembly
Premarket Approval (PMA)
Kaizen
Validation
GMP
U.S. Food and Drug Administration (FDA)
Quality Assurance
Manufacturing
Verification and Validation (V&V)
Injection Molding
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Discover more about SPACELABSWhat is David W Wu email address?
Email David W Wu at [email protected]. This email is the most updated David W Wu's email found in 2026.
How to contact David W Wu?
To contact David W Wu send an email to [email protected]. (updated on August 25, 2024)
What company does David Wu work for?
David Wu works for SPACELABS
What is David Wu's role at SPACELABS?
David Wu is Senior Design Quality Engineer
What is David Wu's Phone Number?
David Wu's phone (404) ***-*292
What industry does David Wu work in?
David Wu works in the Medical Devices industry.
David Wu Email Addresses
David Wu Phone Numbers
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