ANDY PASKO

**** ******** *****, ***** ****, WI **128

Phone 262-***-**** / email: ab2xy9@r.postjobfree.com

Objective:

To obtain a position as Design / Mechanical / Quality Engineer, where my

experience in manufacturing and research engineering will add value to

company operations

Summary:

Medical Device design and testing

FDA regulations 21 CFR part 210, 211, and 820

Experience in CAPA and DFMEA

Plastics Injection Molding, Extruding, Thermoforming

Advanced user of SolidWorks13 CAD software

Work History:

Endoplus USA

431 Lexington Drive, Buffalo Grove IL 60089 Jan 2013 to

June 2013

Contract/ Design Engineer - Medical Devices (Reusable Stainless Steel

Laparoscopic Instruments)

. Lead CAPA redesign of grasping jaw mechanical linkage failure.

. Used SolidWorks to create solid models, configurations, and assemblies

of new jaw linkage.

. Created Design Change Control documentation including Prints, Bill of

Materials, Routers, Inspection sheets.

. Maintain project plans, collaborated effectively with Sales,

Manufacturing, Quality, Regulatory, Customers, and Vendors.

. Lead CAPA investigation of customer complaints of handle closure

issues.

. Conducted thorough root cause analysis of process and design, DFMEA.

. Identified error in welding manufacturing process.

. Designed new welding fixtures for production.

. Wrote testing protocols and reports to confirm that issue was

resolved.

. Completed documentation to close the CAPA

. Conducted IQ, OQ, PQ validation for production CNC's, Lathes, Mills,

and testing equipment.

. Troubleshoot and resolved manufacturing floor production issues.

. Designed carbide profile cutting tools for custom milling process.

Kelly Services

Hospira Inc.

375 N. Field Drive, Lake Forest IL 60045 April 2012 to

Jan 2013

Contract/ Design Engineer - R&D Consumables

. Engineer Lead for remediation of IV Set tubing complaints of kinks and

damage.

. Created requirements for DID (Design Input Document) based on customer

needs (VOC).

. Conducted thorough root cause analysis of process and design, DFMEA.

. Presented travel report to management identifying errors identifying

errors in tubing assembly, spool storage, and final product packaging.

Made recommendations for errors found.

. Used SolidWorks CAD to design new packaging carton concept

configurations to reduce shipping damage.

. Conducted Design Reviews to provide team progress updates for each

step taken.

. Provided minimal invasive cost effective strategies for new packaging

designs.

. Created Design of Experiment (DOE) for new packaging concepts.

. Wrote packaging test protocols per ASTM standards.

. Provided management with team recommendations and cost estimation for

each packaging concept.

Randstad Engineering

Baxter Healthcare Corporation

Route 120 and Wilson Road, Round Lake IL 60073 Sept 2011 to

April 2012

Contract/ Mechanical Engineer - Bioscience Division

. Provided support for new product development of reconstitution device

used to mix and transfer drug for IV administration.

. Created test protocols for needle and spike performance.

. Designed specialized holding fixtures for INSTRON and MTS

instruments.

. Provided support for customer complaints of leaks in reconstitution

devices.

. Conducted thorough root cause analysis of process and design, DFMEA.

. Used SolidWorks to design and develop a vacuum apparatus to quickly

test devices for leaks. With this fixture 5 out of 1000 device were

found have leaks. Devices were dissected and root cause was found to

be excessive molding flash.

. Used SolidWorks CAD to design a new core pin for improved shut off to

prevent molding flash.

. Presented new core pin design to Management, Molding, and

Manufacturing.

. Wrote and conducted testing protocols to confirm that issue was

resolved.

Fenwal Inc.

Three Corporate Drive, Lake Zurich, IL 60047 March 2007 to

May 2011

Senior Technologist - Disposables Engineering

Patents:

US 200******** - Flow controllers for fluid circuits. September 2009

US 201******** - Flexible housing filter and methods for making such

filter. April 2010

US 201******** - Automated methods of whole blood processing. April 2012

. Lead CAPA investigation of customer complaints of container and tubing

leaks, and tubing kinks.

. Conducted thorough root cause analysis of process and design, DFMEA.

Identified root cause errors.

. Used SolidWorks for design and manufacturability of new phlebotomy

needle design.

. Created methods and fixtures for needle tip performance testing.

. Collaborated with mold maker for prototype tooling.

. Used SolidWorks to design prototype pneumatic assembly station.

. Designed new RF sealing dies for prototyping of flexible filters and

containers.

. Setup of RF sealing equipment for experimental and prototyping.

. Designed thermoform trays, wraps and carton for packaging of

collection set kits.

. Created Design Change Control documentation including Prints, Bill of

Materials, Routers, Inspection sheets.

. Wrote and conducted packaging test protocols per ASTM standards.

. Created standard operating procedures for testing tubing bonds, peel

strength, activation force, torque force, spike insertion, and bend

force testing for devices and contrainers.

. Programmed testing methods for INSTRON instrument using BlueHill

Software.

. Wrote and conducted protocols for pump motor speed controls.

Baxter Healthcare Corporation

Route 120 and Wilson Road, Round Lake IL 60073 June 1998 to

March 2007

Senior Technologist - Biopharma Solutions Division

As part of a design team our main focus was to create new reconstitution

devices used to mix drug into I.V. solutions. I created solid models and

working prototypes of plastic component and mechanical assemblies in

alignment with Voc. I provide proof of concept with tolerance stack-up

analysis of precision plastic assemblies. The assemblies consisted of

snaps, slides, o-ring seals, spikes, needles, rubber seals, over molded

materials, ultrasonic welding, UV adhesive, e-beam sterile connections. I

have experience in machine and product validation in manufacturing plants,

mold inspections, and in troubleshooting production equipment.

. Solid Model 3D Design and 2D Drawing

. Medical device testing

. Needle performance testing

. Packaging and distribution / Product life studies

. Experience with ETO, Gamma, Steam, and e-beam sterilization.

. Troubleshooting Automation Equipment

. Process and Machine Validation IQ,OQ,PQ

. Prototype and Production Molds

. DFMEA - Design Failure Mode and Effects Analysis

. Materials and Packaging Testing (ASTM and ISO Standards)

Baxter Healthcare Corporation

Route 120 and Wilson Road, Round Lake IL 60073 June 1995 to June

1998

Senior Technician - I.V. Systems Technical Center Division

The main focus of the Technical Center is to improve product and process

performance and in cost reduction of new and existing product portfolio.

. Compression and tensile testing of bonds and seals using INSTRON and

MTS.

. Design holding fixtures for testing.

. Materials and Packaging Testing (ASTM and ISO Standards)

. Experience with ETO, Gamma, Steam, and e-beam sterilization.

. Incoming first of code inspections using OGP Smartscope, Leica

microscope, Hirox microscope, Nikon V-12 optical comparator.

. Laboratory coordinator - Improved product staging area and parts

inventory.

. Member of EHS safety and ergonomics committee.

Recognition:

. Awarded in 2005 for improvement for robust design of mechanical snap

for Ulti-Mate universal drug reconstitution device. Machined plastic

prototypes.

. Awarded in 2003 for design idea of tamper shrinkband from concept to

final product stage. Designed and modified steel cutting blade for

Hishi Plastics U.S.A. for longer pull-tab.

. Awarded in 2002 for improving a click and turn feature on Vial-Mate

reconstitution device.

Lavin & Sons Refiners & Smelters

2028 North Chicago, IL 60064 Aug 1991 to June

1995

Laboratory Bench Chemist

Duties were to analyze brass during the smelting and final mixing process

and give report of elements to Plant Forman. The final brass material, in

form of ingot or bar, was shipped by railway to customers such as Kohler,

Moen, Delta, Schlage, Excelsior Brass Works, Master Lock Company, and

Precision.

. X-ray analysis of ferrous and non-ferrous raw brass alloys.

. Wet solution analysis of raw brass alloys by atomic absorption methods.

. Report results to Plant Foreman.

. Calibration of all instruments using ANSI standards.

Baxter Healthcare Corporation

Route 120 and Wilson Road, Round Lake IL 60073 Feb 1988 to Sept

1991

Laboratory Technician - Applied Sciences

Projects: Hemoglobin Blood Substitutes, Peritoneal Dialysis

Main duties were to supported team of doctors and scientists to assess a

blood substitute derived from bovine blood. Acute and long term testing

were conducted in laboratory.

. Polymer Biomaterial Toxicity testing.

. Hemoglobin efficacy evaluation.

. Safety efficacy of kidney dialysis methods.

Education:

BS- Technology Management

Keller Graduate School / Devry University, Chicago Illinois

AAS- Electronics Engineering Technology

College of Lake County, Grayslake Illinois

Solid Works Training

CATIA, Buffalo Grove Illinois

AutoCAD Training

CADD/CAM Tools Inc., Arlington Heights Illinois

Software Experience:

SolidWorks

AutoCAD

Vellum Graphite

Vectric Aspire 3

Corel Draw

MS Office

SAP Business Management Software

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