The document discusses the roles of design assurance engineers and Megan McGuire in the medical device industry. It provides an overview of different job titles in medical device development and manufacturing. It also outlines various testing responsibilities of design assurance engineers, including gage R&R studies, design verification, risk management, and test method validation. Design assurance engineers ensure that medical devices are properly designed and tested to FDA standards before commercialization.

1. Design
Assurance
Engineering (DAE)
Defined
Two DAE members and their roles
in the medical device industry
Presented by:
Liz Balmores
Megan McGuire

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Endovascular Therapies
http://www.patient.co.uk/diagram/Arteries-Of-The-Body.htm

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Job Titles in the Medical Device Industry:
 Design Assurance Engineer
 Reliability Engineer
 Design Quality Engineer
 Product Quality Engineer
 Quality Engineer
 Quality Engineer – NPD

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R&D Engineers
Process Development Engineers
Regulatory
Clinical
Marketing
Project Managers
Manufacturing Engineers
Design Assurance Engineers
Operators
Technicians
Equipment & Calibration
Complaints Group
Manufacturing Quality Engineers
Packaging

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• Gage R&R Studies
• Design Freeze
• Design Verification
• Design Validation
• Biocompatibility
• Competitive Testing
• Shelf Life
TEST, TEST, TEST
21 CFR 820.30 Design Control Guidance for Medical Device Manufacturers

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DATA ANALYSIS

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Risk Management

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Documentation

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Why Test Methods?

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What are we testing?

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How Do We Test?

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Repeatability
Reproducibility
Test Method Validation

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Test Method Documentation

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What my parents think I do
What my fiance thinks I do What I think I do
What my friends and sisters think I do
Design Assurance Engineer

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What We Really Do:

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