Engineer Six Sigma

Nellie Stewart

Email: *********@********.***

Address: PO Box 40924

City: Cincinnati

State: OH

Zip: 45240

Country: USA

Phone: 513-***-****

Skill Level: Management

Salary Range: $100,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

NELLIE STEWART

Cincinnati, OH 513-***-**** *********@********.***

MANUFACTURING ENGINEERING /NEW PRODUCT DEVELOPMENT ENGINEERING

Six Sigma Black Belt ~ Lean Manufacturing ~ Industrial Plastics

Medical Device Manufacturing ~ New Product Development and Launch

Process Development ~ Team Building and Mentoring

* Demonstrated record of reducing costs, maximizing production uptime and efficiency, and meeting / exceeding quality requirements by developing, implementing, maintaining, and continuously improving manufacturing processes.

* Experienced in manufacturing processes in accordance with FDA QSR`s, ISO 9001, and cGMP`s.

* Demonstrated exceptional leadership in fast-paced environments. Received Standards of Leadership Award 2004 and 2006.

* Experience participating in the planning, execution and development of new products.

* MBA with BS, Mechanical Engineering.

PROFESSIONAL EXPERIENCE

ETHICON ENDO-SURGERY, Cincinnati, OH

Senior Manufacturing Engineer / New Product Development Engineer (1997 - 2012)

* Experience in the medical device industry in development, as well as deployment of Quality Systems (FDA 21 CFR Part 820, ISO9001), and process controls and continuous improvement methods.

* Led Investigations for potential Intellectual Property opportunities for nano-crystaline coatings for medical devices across the Johnson&Johnson MD&D sector.

* Ensured quality and necessary controls plans were in place, including FAIR, FMEA, Process Flow Map, Cycle time, and Mold Flow Analysis for SIM injection molded components, by working with supplier`s Engineers and Quality during component development phase.

* Worked with suppliers to resolve problems with post-production components. Resolved issues, eliminated further recurrence of problems, and documented successes for lessons learned.

* Interfaced with supplier`s Engineering and Quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements of the project. Drove corrective and preventive actions to preclude recurrence of identified issues.

* Identified and prevented quality defects by developing control plans that defined the supplier`s processes, identifying areas of risk, and instituting quality tools and programs.

* Used Six Sigma principles to resolve CAPA(s) and other identified problems, using FMEA(S), Root Cause Analysis, and DMAIC methodology. Collaborated with cross functional teams to obtain optimal results.

* Drove continuous improvement in supplier performance through utilization tools such as DOE, Six Sigma, DMAIC, FMEA, SPC, 5-Why and Root Cause Analysis, and Lean.

* Led cross-functional and cross company team by leading a team of associates in defining and implementing the Strategies for the Manufacturing Development Center (MDC) to the establishment of the 2005 MDC strategies for the alignment with strategies for the Ethicon Endo-Surgery organization as a whole from Worldwide to the MDC.

* Lead Manufacturing/Development Engineer for the plastics components in the Harmonic Franchise. Primarily responsible for supplier management activities as well as working with the New Product Development teams internally.

* Defined, evaluated, and improved the stability of components pre-production as core team member for the Component Stability Initiative.

* Facilitator for Equipment Maintenance group with 13 direct reports, with responsibility for keeping production equipment downtime low, and decreasing disposables cost:

o Turned around poor performing business, service and function for the equipment team for production equipment.

o Decreased equipment cost 20% and cost to maintain equipment 12% prior to relocation to Mexico.

INTERBOLD/DIEBOLD, Canton OH

Senior Manufacturing Engineer (1992 - 1997)

* Provided Manufacturing Engineering support for metal products from design to production. Developed flat sheets and machine stamping and bending sequences prior to delivery to the shop floor.

* Coordinated solutions to manufacturing and equipment issues and implemented changes.

* Maintained resources to ensure projects were completed on time and within budget.

* Defined, documented, and implement manufacturing processes, tooling and quality procedures.

* Implemented the use of standard tool sets for new and existing products.

CRAY COMPUTER CORPORATION, Colorado Springs, CO

Engineer II (1989 - 1992)

* Responsible for specifications for twisted pair wire based on standards and Time Domain Reflectometry and Propagation Time Delay analysis.

* Developed parameters and guidelines for reliability testing and incoming inspections for micro-miniature I/O connectors.

* Assisted in the development of the wiring and cable harnessing scheme for the interconnect between modules for the CRAY-3 computer.

* Researched and implemented the use of a micro-miniature fuse which also included the implementation of the fuse insertion process used in production.

* Designed AC and DC bulkheads using NEC guidelines of industrial wiring practices. Mechanically packaged the cabling and wire harnesses for electronic assemblies in the control pod of the CRAY-3 computer.

* Liaison for the Mechanical and Electrical Design Support teams, responsible for the liquid cooling system and packaging of the CRAY-3 computer.

EDUCATION

Masters of Business Administration, University of Phoenix, 2008

BS, Mechanical Engineering, John Brown University, Siloam Springs, AR, 1989

AAS, Electronic Engineering Technology, John Brown University, Siloam Springs AR, 1988

AAS, Mechanical Design and Engineering Technology, Phillips County Community College, Helena, AR, 1980

CERTIFICATIONS

Six Sigma Black Belt

PROFESSIONAL AFFILIATIONS

APICS

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