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Manufacturing Engineer

Location:
Antioch, Illinois, 60002, United States
Salary:
Negotiable
Posted:
September 29, 2018

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Resume:

John Kurowski

** *. ********** *****

Antioch, IL 60002

ac677h@r.postjobfree.com

847-***-****

Professional Summary

•Highly motivated team player with exceptional communications skills and extensive engineering experience.

•Gained additional knowledge of injection molding, sterilization processes and product development processes and packaging studies for medical devices while at Baxter and AbbVie.

•Proven excellence in Lean Manufacturing implementation, problem solving, creative design, and engineering.

•Designed and developed the injection containers for Humira medical devices for arthritis at AbbVie and ran verification and verification tests on the medical devices.

•Demonstrated skills with Kaizen, TMV, FMEA, DFMEA, APQP, and ISO 13485.

•Displays a solid technical understanding of engineering principles and procedures.

•Remediation of out of date and code of materials for environmental safety, packaged in proper Bio Hazard containers for disposal.

Areas of Expertise

•Designed tools for manufacturing, assembly lines, fixtures, gauges and prototype sample products for marketing.

•Improved current processes.

•Supervised four toolmakers, tool room, and various tool room projects.

•Evaluated new product introduction with marketing, sales, production managers and sales engineer

•Designed machines and tooling for all products used in molding, assembly, testing and packaging.

•Lean Manufacturing

•Laser and ultrasonic welding

•New Product Design for tooling and Molding

•Hydraulic and Pneumatic Design

•IQ,OQ,PQ Qualifications,DFMEA,ISO 13485,DHF

•Manufacturing Documentation for New Product Design and Assembly

•Tool Maker /Tool room Manager

•New Product Development of Disposable Devices

•Supervised team members on projects and timelines

Technical Summary

•SolidWorks 2017, Creo 2014, AutoCAD 2013, AutoCAD Inventor

•Minitab

•Knowledge of GMPs, FDA guidelines, purchasing practices and process validation

•Microsoft Office and Project, Visio Software

•Journeyman Tool and Die Maker with Family Business

•Lean Manufacturing, Kemper Tregoe, Toyota Production System ( TPS)

•QS90002, TS16949,UL,ISO 13485

•Experience with medical product development and medical product lifecycle management.

•Strong leadership potential and demonstrates eagerness to learn and continuously improve.

•New Product and Process Development Management,Tool Room Manager

•DHF ( Design History Files ) for Device Medical Products

Professional Experience

Lakeshore Engineering Antioch, IL

Manufacturing Freelance Consultant 11/2017 - Present

Provided Manufacturing Engineering services to various companies.

Worked with Tool and Machine Designs, Lean Manufacturing, and Plant Layout.

Worked with various medical companies designing fixtures for device testing

Baxter Healthcare Corporation Round Lake, IL, R&D Innovation Engineer 09/2017 - 09/2017(Contract with Damcosoft) Worked for 3 weeks due to surgery.

Provided engineering support to all Baxter Products Facilities in North America and Europe and suppliers.

Design History Files (DHF) for Baxter Disposable Devices Updated and Released New Revisions for new products and Remediation to update new and existing products with offshore (EU) divisions and present US locations.

Worked with offshore suppliers for various product lines

TMV - Test Method Validations for existing and new lines

ISO 13785

Lakeshore Engineering Antioch, IL

Manufacturing Freelance Consultant 7/2016 – 09/2017

Provided Manufacturing Engineering services to various companies.

Worked with Tool and Machine Designs, Lean Manufacturing, and Plant Layout.

AbbVie, North Chicago, IL 02/2015 – 07/2015 Sr. Mechanical Engineer Combination Product Development (Contract with Insight Global)

Provided engineering support to all AbbVie Products Facilities in North America and Europe and suppliers.

Designed new medical devices and oversee all medical testing and FDA Documentation.

Experience in Humira High Concentrate Alternate Auto injector (AAI) Disposable device

Worked with offshore Abbvie Divisions and 3rd Party Suppliers for Humira Product Line

Design History Files ( DHF ) for Humira Devices, Updated and Released new Revisions

Lakeshore Engineering Antioch, IL

Manufacturing Freelance Consultant 01/2014 – 02/2015

Provided Manufacturing Engineering services to various companies.

Worked with Tool and Machine Designs, Lean Manufacturing, and Plant Layout.

Worked with various medical companies designing fixtures for device testing

Baxter Healthcare Corporation, Round Lake, IL 05/2014 - 12/2014

Sr. Eng. Bio Surgery/ R&D Engineering (Contract with Randstad ended)

Provided Manufacturing support to all Baxter manufacturing Facilities in North America and European and Asian Manufacturing facilities and suppliers.

Experienced with sheet metal, machining, injection molding, for new and existing products.

Designed new medical devices and oversee all medical testing and FDA Documentation.

Worked with 3D Rapid Prototype for new product designs and testing, TMV Samples.

Demonstrated skills with Kaizen, FMEA, DFMEA, APQP, and ISO 13485.

Tools, Fixtures and Machine Design for in plant manufacturing.

Worked with new S.O.P. for new products, Assembly Processes and Procedures.

Responsible for injection molding for Medical Devices, and New Product Development, Plant Transfers to new locations, IQ,OQ.PQ Validations and Verifications and Electro Mechanical Devices for Medical Devices and disposables, DHF for New products and Remediation to update new and existing products with offshore ( EU ) divisions and present US Divisions.

Provided Manufacturing Engineering services with various divisions within the company.

LakeShore Engineering Antioch, IL

Manufacturing Free Consultant 2009 - 2014

Provided Manufacturing Engineering services to various companies.

Worked with Tool and Machine Designs, Lean Manufacturing, and Plant Layout. Worked with tool and Machine Designs, Lean Manufacturing, and Plant Layout.

Drawings Services as required by company’s needs.

CNH AMERICA LLC, Racine, WI Sr. Manufacturing Engineer 2008 – 2009

Responsible for Valve Assembly and Manufacturing for tractor control assembly from concept to production.

Hydraulic Valve Manufacturing and Assembly Processes. Demonstrated skills in Quality Procedures.

Responsible for new Product Development and prototypes for agriculture and new Tool Designs Assembly Processes and Procedures.

Responsible for Hydraulic Schematics and Hydraulic piping Layouts on Tractors systems Provided Cell Layout for assembly lines.

Troubleshoot production problems on all tractor lines (Case IH Magnum and New Holland).

Brunk Industries, INC. Lake Geneva, WI 2005 – 2008 Sr. Manufacturing Engineer

Responsible for designing new automated machinery and Tooling for Cellular manufacturing for medical assembly from concept to production.

Experienced with sheet metal, injection molding, and casted parts for new and existing products, mechanism design and lean manufacturing.

Demonstrated skills with Kaizen, APQP, New Product Development, laser welding.

Produced medical products for many medical companies including Medtronic’s, Johnson and Johnson and Boston Medical.

Parker Hannifin, Lincolnshire, IL 2003 - 2005 Sr. Manufacturing Engineer

Responsible for designing new automated machinery for Cellular Manufacturing from concept to production.

Experienced with sheet metal, injection molding, laser welding, and casted parts for new and existing products, mechanism design, laser welding, ultrasonic welding and lean manufacturing.

Demonstrated skills with Kaizen, FMEA, DFMEA, APQP, and New Product Development. Supervise 6 Tech Engineers.

Responsible for Hydraulic System Integration.

Education

BSME University of Illinois at Chicago/UIC



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