Principal Quality Engineer at Cardinal Health
Greater San Diego Area
- Past
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- Principal Quality Engineer at Cardinal Health
- Process Engineer at General Atomics
- Senior Software Quality Engineer Specialist at Cubic
- Senior Engineer at Ericsson
- Senior Advisory Engineer at IBM Global Services
- Network Administrator at CIGNA
- Education
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- Carnegie Mellon University
- University of California, San Diego
- University of California, San Diego
- DePaul University
- DePaul University
- Recommended
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25 people have recommended Edward - Connections
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98
connections
- Industry
- Medical Devices
Edward Wu’s Summary
Over 15 years of progressive engineering experience in Telecommunication, Transportation, Defense, Medical Device, and Insurance companies. Experience in product development, system engineering, system testing, quality assurance, process improvement, and program management. Managed test teams. Built and maintained good customer relationships. Possessed excellent problem-solving skills with detailed-oriented focus.
Led test teams and worked with customer representatives on test planning and test strategy. Performed verification of desktop and enterprise software applications. Types of software verification performed include component test, system integration test, performance test, adversarial test, and user guide test. In addition, performed verification of hardware systems. Types of hardware verification performed include EMI/EMC test, humidity and temperature test, drop test, rain test, and vibration test.
Edward Wu’s Specialties:
Technical Skills:
User Need Analysis
Product Design Analysis
Use Case Analysis
Requirement Analysis
Risk Analysis
Test Planning
Test Strategy Formulation
System Testing
Root Cause Analysis
Issue Tracking and Resolution
CAPA
Standards and Processes:
ISO 9001
ISO 13485
ISO 14971:2007
Fault Tree Analysis
FMEA
Capability Maturity Model Integration (CMMI) V1.2
Lean Six Sigma
Software Development Life Cycle (SDLC)
FDA Good Manufacturing Practices (GMP) - 21 CFR Part 820
Edward Wu’s Experience
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Principal Quality Engineer
Cardinal Health
(Public Company; CAH; Hospital & Health Care industry)
October 2007 — May 2009 (1 year 8 months)
Participate in user need analysis, use case analysis, risk management, requirement analysis, test case analysis, and user manual reviews. Conduct internal project audits. Work with Regulatory on 510(k) submissions and Compliance on product safety compliance. Review reported field issues, product change requests, and FDA MAUDA data for issue resolutions and product improvement. Assist project team members in understanding and following global processes. Qualified commercial software testing tools for coverage analysis, test complexity analysis, and test automation. Participate in corrective and preventive actions on process and product defects. Support development of medical data communication system software and virtual server projects.
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Process Engineer
General Atomics
(Privately Held; Defense & Space industry)
March 2006 — April 2007 (1 year 2 months)
Performed CMMI-based process improvement and appraisals with focus on Project Management. Provided training on CMMI. Conducted root cause analysis on system failures and part failures. Managed product defects from inception to resolution. Witnessed system testing. Participated in Material Review Board (MRB), Change Control Board (CCB), and Software Engineering Process Group (SEPG).
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Senior Software Quality Engineer Specialist
Cubic
(Public Company; CUB; Computer Software industry)
January 2003 — March 2006 (3 years 3 months)
Led testing efforts on multi-million system projects. Formulated test strategy. Managed test resources. Oversaw a team of software quality engineers on both system and software projects. Worked with government representatives on program planning, resourcing, reporting, issue resolution, and product quality assurance. Performed hardware and software verification.
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Senior Engineer
Ericsson
(Public Company; ERIC; Telecommunications industry)
August 1998 — January 2003 (4 years 6 months)
Prepared test cases on wireless systems. Conducted component, system integration, performance, and adversarial tests. Managed test resources. Managed product defects from inception to resolution.
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Senior Advisory Engineer
IBM Global Services
(Public Company; IBM; Information Technology and Services industry)
1997 — 1998 (1 year)
Qualified vendor equipment for subscribed customers. Prepared user manuals and installation guides. Performed system testing. Coordinated new release testing in Europe and Asia. Managed the local area network in the lab.
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Network Administrator
CIGNA
(Public Company; CI; Health, Wellness and Fitness industry)
1990 — 1997 (7 years)
Supported network installation, maintenance, and upgrade. Coordinated with corporate IT on network and software upgrade. Provided training on using software applications. Assisted users on resolving hardware and software issues.
Edward Wu’s Education
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Carnegie Mellon University
Certifications , Capability Maturity Model Integration (CMMI) v1.2 , 2006 — 2007
Introduction to CMMI, version 1.2
Intermediate Concepts of CMMI version 1.2 -
University of California, San Diego
Certification , System Engineering , 2004
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University of California, San Diego
Certification , Project Management , 2002
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DePaul University
Master of Science , Telecommunication Communication Systems , 1997
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DePaul University
Bachelor , Marketing , 1991
Additional Information
Edward Wu’s Groups:
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SQA - Society of Quality Assurance -
Healthcare IT - Careers, Jobs & Opportunities -
Pathfinder Communicators
Edward Wu’s Contact Settings
Interested In:
- career opportunities
- consulting offers
- expertise requests
- reference requests
- getting back in touch
