Donald R. Bufford (***)

Manufacturing, Industrial and Process Engineer

**** ****** ******* - ******, ******** 80207

Phone 303-***-**** Cell 720-***-**** Email: nc6b7o@r.postjobfree.com

Profile, Special Skills and Major Accomplishment:

• Comprehensive experience in manufacturing, industrial and quality engineering, including full responsibility for

products from design concept through production. Responsibility included manufacturing project engineering,

project management, scheduling, developing standards, project status reporting to management and customers.

• Perform strategic planning, competitive analysis and advanced operational planning for long term profitability.

• Implemented new innovative cost savings programs that introduced Lean Six Sigma Methodology into small and large companies. Set up domestic and international vendor quality supply chain programs for low and high volume.

• Provided project management and engineering support for multiple construction and manufacturing projects.

• Headed production efficiency improvement programs and teams that implemented Lean Six Sigma Methodology. This program saved over $900,000 1st year, by improving vendor and production quality by 80% and increased productivity over 400%. These improvements increased annual sales volume over $9,600,000 in 6 months.

• Set up domestic and international vendor quality supply chain for low and high volume products.

• Used Lean Six Sigma Methodology and Industrial Engineering Efficiency Improvement Techniques to develop a new manufacturing operation plan that generated over $27,000,000 saving over 10 years with 4 yr payback for new facility construction and automatic equipment installation.

• Experience with new product design, process development, facility lay out, special tooling design, equipment installation, start-up, validation, testing, training, equipment and new product verification and validation (DHR, DMR, IQ, OQ, PQ PFMEA, FTA, AIP and PMA’S).

• Trained in World Class Good Manufacturing Practices and Regulatory Requirements for quality management documentation systems, and new products PMA process (ISO, FDA 21CFR 820-GMP 13485,

21CFR 814.20-42 PMA- certifications, ASME Y 14.5, QSR, UL, DOD, EPA, DOT, OSHA, RoHs) etc.

• Exceptional at managing new products transfer into manufacturing and supporting daily manufacturing and production operations. CAPA and Warranty Compliance Programs that included FMEA and root cause analysis.

• Strong analytical ability to identify, and solve technical and non-technical, electro-mechanical design and production problems. Experience working with small and large manufacturing operations low and high-tech.

• Knowledgeable of computer management systems for product design, bill of materials, manufacturing, inventory control, quality control and production management. Familiar with SAP, MRP, HMI, SCADA, PLC Programming Excel, AutoCAD, Pro E, Solid Works, Windows, Power Point, MS Project and Project Manager.

• Experience with machining, metal fabrication, molding, mechanical and electrical system design, S/W & H/W integrations, automatic processing equipment, PLC programming start-up and validation.

• Efficient at developing process documentation, performance standards, training programs and technical reports

required to introduce new products into production. Very effective implementing Lean Six Sigma to solve daily production problem.

• Independent, high-energy, results-oriented, self-starter professional as well as a team player and project leader.

• Project management skills include all areas of project oversight, maintaining project budget, resource planning,

project scheduling, status reporting and supervising personnel.

Education and Special Training:

M.S. Industrial Engineering 2009 Hill University, Humble, TX.

B.S. Engineering Technology -Mechanical and Industrial Engineering, Hill University, 1999

Business Administration – Marketing – Engineering Nebraska Western College, Scottsbluff, NE.

Completed Certification program for Machine Shop Technology/Fabrication Operations Nebraska Western College

Completed Certification program for Lean Six Sigma Methodologies/Hill University

Lean Manufacturing Technology- Statistical Process Analysis - Total Quality Management Control System Training

FDA-QSR Training / FDA 21CFR-820-GMP-13485 Training - ISO 9000-2000 Compliance Certification Training

MS Project Management and Scheduling - Equipment Installation start-up Testing and Validation

Donald Bufford – Manufacturing, Industrial and Process Engineer Resume Page -2

Education and Special Training: (Continued)

Construction Project Management - Construction Project Estimating- Construction Project Health and Safety

Writing GMP Protocol – verification and Validation Certifications for Equipment, Process, Tooling Dies and Fixtures

Intellectual Property Protection-Researching and filing Patents-System Automation-PLC installation/Programming

Product Design for Manufacturability - Design Transfer to Manufacturing - Pro Engineering - AutoCAD – Solidworks

Machining– Injection Molding – Metal Fabrication – Electro Mechanical assembly – H/W and S/W System Integration

Experience:

Manufacturing Project Engineering Manager, D&B Engineer Services (Arvada, CO) 10– 02 to present

Lead engineering teams that set-up new manufacturing and production operations to generate efficiency improvements

for a number of different companies using Lean Six Sigma Methodology. Responsibilities include developing design,

quality, procurement and production documentation. Developed procedures, production standards, facility layout,

production tooling and product manufacturing quality plans. Develop verification and validation documentation required

to ensure compliance to all DOE, DOD, FDA, GMP PMA’S, ISO, EPA and OSHA regulations. Additional

responsibilities include preparing products BOM's, tooling, equipment and processes quality documentation for domestic

and international quality supply chain management systems and solving production problems.

Sr. Manufacturing / Industrial Project Engineer, Colorado Medtech, Inc. (Boulder, CO) 6-96 to 8-02

Responsibilities included engineering support for multiple products introduced into manufacturing. This included new

and existing electro-mechanical medical devices and high volume medical disposable products. Developed and maintained manufacturing documentation required to ensure compliance with regulatory standards and agency policies (i.e. FDA, ISO). Resolved production and quality problems generate ECO'S and cost reduction measures in house and at vendors. I managed the design and manufacturing team that developed specifications and cost for sales proposals.

As Sr. Manufacturing Project Engineer for the 60kw (A MRI generator system). I managed the implementation of Lean Six Sigma projects that generated $950K in annual cost savings and increased monthly production by over 400%. This program increased annual sales revenue by $9,600,000.00.

Operation Manager Environmental Safety Clean /Advanced Mfg. Enterprise (Denver, CO) 4-90 to 6-96

Managed the company’s contract-engineering, design and installation services for custom air control enclosures,

clean rooms, decontamination labs and custom automation equipment. Lead the company’s remediation, cleaning,

and decontamination operations and marketed these services to the following industries; manufacturing, chemical,

bottling, brewing, petroleum refining, waste treatment, pharmaceutical, food processing, nuclear, aerospace, military

and semi-conductor manufacturing. I managed 14 employees and was responsible for overseeing Denver division operations. Developed sales proposals and presentations. Provided technical support ensuring compliance to design specifications and government regulations. Maintained project budgets and customer relations.

Sr. Manufacturing / Industrial Engineer, Bard Electro Medical Systems Inc. (Englewood, CO) 7-86 to 3-90

Provided manufacturing and industrial engineering support for the manufacturing of electronic surgery equipment,

generators and disposable surgery products. Ensured manufacturing process and documentation compliance to FDA,

GMP, QSR, ISO and UL requirements. This included validation for equipment and manufacturing processes.

Set-up efficient assembly and testing systems for disposable and Electro-mechanical assemblies. Prepared product

documentation and tooling for supply chain operations.

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