Ralph H. Koussa

R alph

*** *. ******* **., *******, CA 91506 c: 413-***-**** e: r acg5sz@r.postjobfree.com

*** * ******

Career Objective

Diversified manufacturing experience in high and low volume production with an extensive background in

manufacturing, mechanical, processing and validation engineering. Demonstrated success in int roducing

new products into production, and in developing, implementing and managing new processes to improve

quality and productivity. Hands-on experience in fabrication, machining, assembly and lean

manufacturing. Creative analytical problem solver with excellent team-building skills.

KEY SK I L LS & STRENGT HS:

• Hands on experience in manufacturing medical devices and equipment.

• Comprehensive knowledge of manufacturing processes, manufacturing guidelines, and lean

manufacturing principles.

• Extensive knowledge of standards and FDA regulations.

• Diverse knowledge of product design and quality assurance testing procedures.

• Well versed in SolidWorks, medical device tools, and testing equipment.

• Skilled in communicating effectively with strong organizational and management skills.

Education & Licenses

WR IG H T STATE U N I VERSI TY D AYTON, OH

MBA, Project Management, 2004

WR IG H T STATE U N I VERSI TY D AYTON, OH

Bachelors of Science in Mechanical Engineering, 2000

Professional Experience

D I E L ECTR ICS I NC . C H I COPEE, MA

Contract Project Engineer M ay

2011 – Present

• Conduct process validations for a leading medical device manufacturer, which activities

i ncluded wri ting and executing protocols for all steps in the validation process (IQ/OQ/PQ).

• Perform Process Engineering and Six Sigma DMAIC activities which include the following:

p rocess capability studies, design of experiments (DOE), process maps, cause and effects mat rices,

PFMEA’s, SPC, Measurement System Analysis (MSA)/Gage R&R, ANOVA.

• Use Lean Manufacturing principles such as Kaizen events and value stream mapping to

eliminate unnecessary waste from existing production lines.

• Provide technical engineering direction, analysis and recommendations for New Product

Development to successfully launch new products into active production in a t imely and cost effective

manner.

• Interact with customers to provide Engineering support during various phases of projects and

new product development.

• Create standard operating procedures, Device History Records, Purchase specs, and Inspection

p lans for new product designs.

• Design and build test fixtures for product testing and analysis as well as perform test method

validations.

CI R TEC MED ICAL SYSTE MS E AST L ONGMEADOW, MA

M anufacturing Engineer Team Leader Dec

2009 – March 2011

• Provide both Functional and Technical Supervision to a manufacturing engineering team in

t he areas of process development, process improvement and streamlining, as well as project

management.

• Generate process control documents for a wide range of contract manufacturing and assembly

i ncluding disposables, implantable devices, surgical equipment and diagnostic devices.

• Ut ilized process control charts and lean techniques to revamp several production line processes

to increase productivity and overall quality.

• Championed project to int roduce Statistical Process Controls to the workforce as a means to

determine process capability; t rained fellow engineers and production personnel.

• Review standard job orders, create pilot/non standard job orders, schedule work centers,

machine t ime and allocate production resources as necessary.

• Presided over production process optimization, manufacturing equipment specification, tooling

& f ixture design, and all phases of manufacturing cost reduction.

• Developed thorough knowledge of FDA Good Manufacturing Process (GMP) regulations and the

ability to effectively operate in the regulatory environment.

GE I NF RASTRUCTURE, T RANSPORTAT ION

E R I E, PA Mechanical Design Engineer – Propulsion Systems Engineering

M ay 2009– Nov 2009

• Functional lead role for several customer driven reliability projects on AC and DC locomotive

T raction Motor systems.

• Perform root cause analysis on field failures, DFMEA, JSA, design analysis, solution and

i mplementation.

• Create detailed test plans to perform failure analysis, validate new component int roductions,

and run field tests.

• Generate field maintenance instructions, update assembly work scope and repair specifications

associated with design modifications.

GE I NF RASTRUCTURE, T RANSPORTAT ION

E R I E, PA PRODUCT DEVELOPMENT ENG I NEER-CABS A ND STRUCT URES ENG I NEER I NG

April 2007 – April 2009

• Create new packaging designs for various aspects of the locomotive cab structure.

• Ini tiate engineering change orders to correct design issues related to new product information

such as models, drawings, bills of material and purchase specifications.

• Interface with designers and drafters on designs, detailing, and releasing of components and

systems for both new and current products.

• Provide production support and recommendations to assemblers to successfully carry out design

modifications.

• Coordinate and consult with departments outside engineering such as manufacturing and quality

to ensure design changes are incorporated into the manufacturing process.

• Plan and execute test protocols to ensure component conforms to GE specifications.

• Ensure that all mechanical structure design work is FRA compliant.

TYCO HEALT HCARE/LUDLOW

C H ICOPEE, M A M anufacturing Process/Validation Engineer

Apri l 2005 – April 2007

• Lead and drive Kaizen activities to streamline process in the areas of defibrillators and medical

charts using lean manufacturing techniques.

• Lead continuous improvements teams to resolve daily production problems and explore areas of

opportunity

• Lead internal quality audit teams to ensure compliance with FDA regulations

• Ut ilize lean manufacturing and Six Sigma tools to eliminate waste and increase productivity.

• Excellent t roubleshooting and problem-solving skills.

• Knowledge of statistical techniques, SPC, FMEA, process mapping, and r isk analysis.

• Excellent technical writ ing ability and team management skills.

• Knowledge of Quality System regulations, GMPs, and ISO requirements.

T YCO H EALT HCARE /M ALL I NCKROD T C I NC I NNAT I, O H

M anufacturing Engineer Feb

2004 – April 2005

• Developed testing methods to improve quality and reduce costs for new and existing medical

devices.

• Designed, developed, and executed validation protocols for new products.

• Identified r isk areas and potential product design issues and recommend design solutions.

• Implemented engineering change orders including drawings, processes and equipment

i mprovements.

F UJ I TEC AME R ICA, I NC .

L EBANON, OH P roject Engineer

J an 2000 – Aug 2004

• Designed elevator components and layouts for geared, gearless and hydraulic elevator systems.

• Investigated new designs to provide cost reduction, standardization, and streamline production.

• Prepared design and order specs for high profile custom and standard elevator systems.

• Collaborated with vendors, architects and customers to resolve job design issues.

Of Note

COMPUTER SKI LLS:

• Software: MS-Word, Excel, Project and PowerPoint.

• Operating Systems: Windows, DOS, and UN IX.

• Languages and Tools: Mini tab, AutoCAD, UniGraphics, SolidWorks, Chart Runner.

CERT IF ICAT IONS :

Lean Manufacturing Certification

• EKG 8 (sensors production line): Championed lean manufacturing project to streamline

changeover procedure of foam cutting dies by utilizing 5S and SMED techniques in order to establish

a s tandard setup procedure and reduce non-value added actions. The outcome was a reduction in

i nventory levels of supporting material, increased uptime, improved ergonomics, safety, and

manufacturing f lexibility. Total savings $45,000.

• Press 4 (medical charts production line): Championed lean manufacturing project to design and

optimize a cellular design for medical chart paper printing, shrink wrapping and packaging process.

T he focus of the project was to design a “U” shaped manufacturing cell for this 3-shift assembly line

to increase cycle time while efficiently utilizing overhead. Total savings $75,000.

TRAI N I NG:

• Design and Process FMEA t raining, May 2010`

• GE Design For Six Sigma Green Belt t raining, June 2008

• Tyco Healthcare Lean Manufacturing t raining and certification, April 2006

• Ergonomic Tools for Engineers t raining, December 2005

• ISO 13485 : 2003 In ternal Auditor certification, June 2005

• Process Validation t raining, April 2005

*References available upon request.

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