Tim Burge Resume for 2019

1. TIMOTHY P. BURGE, BSME, MBA, CQE, CQA
3881 Zion Hill Rd
Weatherford, Texas 76088
Cell: 817-565-8883
Emails: timburge63@gmail.com, tim.burge@alconlabs.com
SUMMARY of QUALIFICATIONS
Recognized opinion leader with 30 years of medical device experience serving small and large
organizations. Proven ability to influence combined with agility to lead change throughout an
organization. Managed and directed employees to meet targets and exceed expectations. Proficient in
skill sets:
• FDA 21CFR820 and ISO 13485 Quality System Requirements
• Technical File and Design History File Development
• Quality Systems Development
• Lean Six Sigma
• Project Management
• Design and Manufacturing Quality Improvement
• Design Control CFR820.30 and Risk Management EN ISO 14971:2012
• Compliance Audits and External Interface with TUV and FDA
• Medical Device Single Audit Program (MDSAP)
• Supplier Quality
• Metrology
• Department Budgeting and Management
• Process Development
WORK EXPERIENCE
Alcon Laboratories (Novartis) Fort Worth, TX Research and Development Mar 2001-Present
Title: Manager, IOL Design Control and Principal Engineer
Currently direct 4 external contractors in support of compliance to new EU Medical Device Regulation
(EU)2017/745, developing Technical file content and Design History File content for 33 different
products including:
• Ophthalmic Viscoelastic Devices (OVD)
• Balanced Salt Solution (BSS)
• Tamponades for Retinal Surgery
• Intra-Ocular Lens (IOLs) Monofocal and Multifocal
• IOL Delivery Systems
• Custom Paks
• Incisional Instruments
• Non-absorbable Sutures
• Cannula Devices
• Contract Manufactured Devices
Responsible for compliance to design control requirements (21CFR820.30) for Intra-Ocular Lens(IOL)
related products including design reviews and deliverables, product surveillance to review product

2. performance and safety decisions in creation and maintenance of product risk management files. Led
risk management topic and discussion for internal/external audit interface as needed. Managed and
trained direct employees (team of 10) to coordinate design control and technical file activities. Led
teams to conduct non-conformance investigations, root cause analysis and corrective actions. Improve
and develop design control and risk management systems for product development process.
Key Accomplishments:
• 2019: Negotiated agreement with off shore account to support Alcon’s EU MDR compliance initiative
resulting in reduced cost with expedited results(FTW Products)
• 2018: Developed digital DHF process for Alcon Surgical(FTW Products)
• 2017: Alcon Cross Divisional Project- Led the Global Regulatory Affairs team in support of EU MDR to
develop a technical file consolidation process
• 2017: Received Technical Excellence team award for Growth and Innovation- Japan Return to Market
project
• 2001-2016: Implemented multiple IT systems in IOL R&D such as JDEdwards, CATSWEB, Calibration
Manager, and Windchill PLM
• 2016: Nominated and confirmed as Novartis Certified Investigator
• 2016: Created role based training process in IOL
• 2009-2015: Served as the Alcon Subject Matter Expert for Risk Management
• 2015: Trained in expert level Lean Six Sigma through Alcon Operational Excellence
• 2012: Alcon Global Project- Led Alcon’s functional management teams to harmonize the Risk
Management Process across all Alcon medical device divisions
• 2013: Presented device design and development process representing Alcon at Parenteral Drug
Association (PDA), Austin TX
• 2009: Managed R&D technical file team and reduced cycle time for technical file completion
Alcon Laboratories (Novartis) Fort Worth, TX Manufacturing May 1999-Mar 2001
Title: Supplier Quality Assurance Engineer
Responsible for all Fort Worth manufacturing sites (Fort Worth North and ASPEX) secondary packaging
vendor quality. Activities included on-site audits of Suppliers’ Quality Assurance systems, preparation of
standard purchase descriptions and requirements for acceptance, disposition of discrepant material
through material-review-board decisions and development of process validation documents to ensure
effective change control for secondary packaging components.
Cardinal Healthcare (Formerly Baxter International) Jacksonville, TX May 1994 - May 1999
Title: Sr Quality Engineer
Responsible for project management, leadership team for suction canister products, supervise hourly
personnel, nonconforming material disposition, and assist plant management in quality system
maintenance.
Key Accomplishments:
• Promoted to Sr Quality Engineer in 1997
• Installed automated vision system in support of lid assembly product design and process changes.
Vision system development supported the cost savings of an estimated $400K for product design and
manufacturing changes.
• Re-engineered the documentation process for product inspections.

3. • Installed automated vision inspection system equipment in-line with canister production.
• Assisted in plant implementation of Baxter Six Sigma Program.
Surgimedics, Inc The Woodlands, TX Aug 1991 - May 1994
Title: Quality Engineer
Responsible for project management, supervise hourly personnel, process validation, supplier quality
assurance, complaint analysis, and design control for blood collection devices and Custom tubing packs
for Open Heart By-Pass surgery.
Key Accomplishments:
• Interface with FDA. Optimized and documented the sterile packaging process in response to FDA
warning letter.
• Served as Design Control Engineer and Manufacturing Quality Engineer for all new products.
Bristol Myers-Squibb (Argon Facility) Athens, TX Aug 1988 - July 1991
Title: Quality Engineer
Responsible for metrology program, supervise hourly personnel, product qualifications, and design
control.
Key Accomplishments:
• Implemented the facility calibration system
• Led project team to optimize new product Catheter Lab Introducer through Design of Experiments
resulting in increased product confidence and sales.
Mar-Tech Automation and Control Lake Charles, LA Jan 1987 - Aug 1988
Title: Lab Supervisor
Responsible for general engineering duties, supervise hourly personnel, and author calibration
procedures
Key Accomplishments:
• Designed Jack Tester for Boeing
EDUCATION
• McNeese State University- Lake Charles , LA BS Mechanical Engineering May 1986
• Texas Christian University – Fort Worth , TX MBA Aug 2006
ACCREDITATION/CERTIFICATION
• Completed Lean Six Sigma Expert(Black Belt) Training through Alcon
• ASQ: Certified Quality Engineer (# 29121), Certified Quality Auditor (# 15461)
• SIX SIGMA: Baxter Certified Six Sigma Engineer 1996
REFERENCES
• Greg Williams, Head of GCA Audit for Novartis phone # 862-217-1404