Resume of Qualifications

Harvey M. Bakke Messages: 414-***-****

**** *. ******** ** #** E-mail: p4fq74@r.postjobfree.com

Oak Creek, Wisconsin 53154

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Education: University of Wisconsin-Milwaukee

Milwaukee, Wisconsin

Bachelor of Science - Mechanical Engineering

10/19/11 to Oxford Global Resources

5/01/2012 Peabody, MA

Contracted to ST. Jude Medical in Plano Texas as a Manufacturing Engineer to assist in

the validation of their current and future manufacturing processes writing and executing

IQ, OQ, PQ protocols; Test Methods and Test Method Validations.

11/31/09 to Oxford Global Resources

01/15/10 Peabody, MA

Contracted to Apollo Endosurgery as a Manufacturing Engineer. Designed and built test

fixture for their assembly line and performed IQ and OQ documentation for process

tooling

05/07/08 to Oxford Global Resourecs

12/19/08 Peabody, MA

Contract position at Zimmer Orthopaedic Surgical Products in Dover, Ohio

as a Technical Writer.

Developed work/process procedures for the manufacturing and assembly of medical

devices using Informatiion mapping software FS pro, Visio, and Microsoft Word.

12/19/07 to Oxford Global Resources

05/02/08 Peabody. MA

Assignment at Abbott Diagnostics in Dallas Texas as Quality Engineer.

Primary responsibility was investigating, tracking, and trending of customer complaints

using software applications (CATS, TWA, Team Track …etc.) specific to the task.

Grouping related and relevant information in appropriate format for PQA personnel.

Other database verification, maintenance and general support to the PQA group.

06/07 to Oxford Global Resources

10/19/07 Peabody, MA

Contracted to Abbott Spine inc. in Austin Tx. As a Manufacturing/Quality engineer to help in the

dispositioning of returned medical devices that were used in

hospitals on a consigned or loaner basis. Upon arrival at Abbott they

were examined for breakage and function and reworked or scrapped

accordingly.

My main function was to write rework and inspection

procedures for those devices that were to be returned to the field.

Worked with the engineering department to suggest possible design

changes and improvements.

06/05/06 to Oxford Global Resources

10/01/06 Peabody, MA

Contracted to Medtronic inc. in Brooklyn Center, Minnesota as a process development

engineer for new product launch. This included the conceptual and detail design

of close tolerance, miniature, resistance spot weld tooling,trim dies, niobium and nickel

alloy wire cutting, and test fixtures.

Driving outside resources (vendors) to meet timeline and quality requirements.

10/04 to 7/05 Mechanical Engineering Cnslts. 1-414-***-****

Milwaukee, WI 53215

Converted an industrial gas-fired washer to an electrically heated system.

The old system, through the years, had undergone excessive wear and tear requiring

several costly modifications just to keep it limping along. It was very

undependable,inefficient, and costly to operate.

The new electrically heated system was much more economical in that it provided for

better control and utilization (BTU’s/WATT) of applied energy. The controls allowed us to

program a heating schedule for the whole week, through weekends, and even off shift.

7/03 to 10/03 Aries Group Inc.

462 Boston Street

Topsfield, MA 01983

Contract assignment at C.R. Bard Inc. in Glens Falls N.Y.

Designed new method and equipment to grind “SNF” and “RNF” nitinol wire implants.

Their current equipment was not meeting quality standards or production requirements.

The new design improves quality and increases production numbers.

2\02 to 7/02 Oxford Global Resources 1-888-***-****

Contact - Chris Towns

Jupiter, Fl

Contracted with ACMI Surgitek in Racine Wi as an engineer for manufacturing of medical

equipment. The company was shut down in Santa Barbara, Ca and moved to Racine WI.

All existing builds and new builds coming into the Racine facility had to be modified, properly

documented, and validated in compliance with FDA regulations.

Addressed and resolved several product production problems with manufacturing and vendor

personnel, wrote product validation protocols, product validation reports, ECR’s

and NCR’s.

Defined critical/non-critical manufacturing parameters for Incoming inspection and wrote

manufacturing production instructions (MPI’s) for technicians and production personnel.

2/01 to 5/01 Oxford Global Resources 1-877-***-****

Contact - Chris Towns

Beverly, Ma

Worked at Pall/Gehlman Sciences (for Oxford Global Resources) in Ann Arbor, Mi.

There I was contracted to optimize a manufacturing process of one of their intravenous

infusion filters. Most of the work involved equipment modifications, general trouble shooting and

identification and resolution of problems in the ultra-sonic welding area.

2/00 to 2/01 Associated Staffing inc. 770-***-****

Contact - Jim Ragland

Roswell, Ga.

Manufacturing Engineer

Employed as contract Engineer at CCL Custom Manufacturing in Memphis TN. for

The Hewlett Packard co.

Responsibilities included engineering support for production and production equipment

that filled ink cartridges for the Hewlett Packard line of ink jet printers (60cc and 80cc).

Used SPC, and participated in PFMEA of manufacturing processes to assure the

maintenance and improvement of product quality.

Also, was part of a team sent to Hewlett Packard’s manufacturing site in San Diego, Ca.

to learn the ink filling process of their “MIRAGE” line of cartridges (175,350,and 680cc).

After six weeks of learning the operation we disassembled all the equipment,

Identified it, and prepared it for shipment to CCL site in Memphis TN.

As process owner of one third of the line it was my responsibility to coordinate the

move and reinstallation with the various other players, i.e…electricians, technicians,

riggers, and craters. Once the line was on site and reassembled at Memphis the

owners were responsible to get it running, bebug it, train operators and technicians,

perform qualify runs, and validate everything for production.

The entire project required owners along with allocated resources to plan and work

within tight schedules and deliver according to plan.

4/99 to 2/00 Entegee Engineering Group 1-800-***-****

Contact - Richard Furne

Davenport, Iowa

Manufacturing/Process

Engineer at Johnson and Johnson (Personal Care Products)

Improve production numbers on high-speed, high tech manufacturing and packaging

equipment for personal care products (sanitary napkins) from raw materials to final

packaging

Trained new employees on equipment operation, trouble shooting and maintenance.

4/98 to 4/99 PDS Technical Services 1-800-***-****

Contact - Mike Hetzel

Brookfield, Wi.

Conract ed as Manufacturing Engineer at G.E. Medical in Milwaukee, Wi.

Responsible for the removal of 'bottle-neck' in manufacturing processes of CT-SCANNER

detector packs. Designed and developed new grinding procedures, specified and procured new

equipment, designed tooling and fixtures installed new equipment, trained employees, and startup.

Results: tripled output of close tolerance grinding of packs, reduced scrap by 75%, and

improved quality significantly as part of a production ramp-up project.

Documented new process procedures and work instructions.

Installed and implemented coolant/filtering system for CLEAN ROOM manufacturing/machining

of detector packs.

7/97 to 3/98 FSK Associates

Long Beach, North Carolina

Design Engineer

Retooled automated line that assembled front wheel bearings

for the Ford and Chrysler automotive industry in Joplin Mo.

Duties included (but where not limited to) design and installation of pick-an-place units,

modifications to automated testing equipment, redesign of automated assembly fixtures,

testing and assessing applicability of vision systems, and design of heat-treating

fixtures.

8/88 to 8/95 Baltimore Brush and Roller-Division of Cotter and Co.

Cary, Illinois

Engineering Manager

Responsible for the setup, installation, modification, of automated manufacturing and packaging

equipment to be utilized in the new paint roller department. Selected vendors, defined product and

manufacturing specifications, maintained project schedule, production quotas, and budgetary guidelines.

Supervised and led the activities of a three employee quality assurance department

in the development of a TQM/TQC program.

Established production rates and production capacities thru the application of industrial

engineering techniques, identification and resolution of production bottle necks, the optimization of

manufacturing processes, labor utilization, and equipment efficiencies.

Worked closely with the production and maintenance departments.

Involved in company short and long range planning, marketing research, new product

expansion, and continued manufacturing cost reduction programs.

1981 to 8/88 E-Z Paintr Corp

Milwaukee, Wisconsin

Project Leader

Accountable for manufacturing cost reductions-established utilization of direct labor

and optimization of equipment and processeses

Introduced new equipment to internally manufacture and package paint applicator products and

components. Directly involved in the initial conception, design, build, installation, PLC programming

(Allen Bradley “SLC” 100 and 150 controllers) and debugging of special machinery. Supervised and

coordinated engineering personnel and vendor activities.

1979 to 1981 Pressed Steel Tank Co.

West Allis, Wisconsin

Supervisor of Tool Engineering

Directly supervised four Tool Engineering personnel. Designed tooling for the fabrica-

tion of compressed gas cylinders including special threading and cutting tools, stamping

tools, blanking/draw dies and punches, product handling and machining equipment, and

heat-treating fixtures. Implemented a plant-wide tool identification and maintenance

program. Responsible for cost reductions, material selection, heat-treatment tooling, and

providing support to project engineering and the machine shop.

Experience: Performed contract design and engineering functions at various contract houses on a client

request/repeat basis at numerous companies throughout the area including: Bucyrus Erie

corp. (machining and designing of welded joints to AWS standards for heavy plate in the

construction of earth moving equipment ); Allis Chalmers Tractor (transmission

component design,

machining fixtures, and gage design) and Rotary Kiln Divisions( designing welded steel

rotary kilns for taconite mines for the processing of iron ores);

J.I. Case Tractor; Heil corp. (truck and earth moving equipment design);

George J. Meyers Mfg. Co. (bottle filling equipment); Harnischfeger corp. (stack and

store material handling equipment); Jos. Schlitz Brewing Co. (can manufacturing);

Pressed Steel Tank Co.(compressed gas cylinders); Trent Tube mfg. (stainless steel

tube forming and plasma welding process and equipment design); and the Perfex corp.

(Shell and tube bundle heat exchanger assemblies, plasma welding of tubes to sheets and

welded shell fabrication).

Central States Engineering & Fabrication as an Application Engineer

with duties that included cost estimating, design and layout of bulk material handling

equipment (conveyors, rock crushers, and storage bins) and layout and design of

municipal and industrial water treatment systems.

Design and detail of Blast Hole Diggers.

Familiar with AWS and AISC welding standards.

Employed at Lincoln Tool and Mfg. Co. as a Machinist and a Machine and Tool de-

signer in the manufacturing of stator winding equipment for electric motors and

automotive alternators ---very strong "hands on" experience building, debugging, and

installing machinery that has continued throughout my career path.

Employed at Louis Allis company as tool designer (cutting tools, machining fixtures,

gages, blanking dies and tooling for aluminum die casting) in the manufacturing of

Electric motors.

Industrial Engineering classes (MTM) at Maynard Industrial Engineering Institute in

Columbus, Ohio.

Skills: AutoCad 2D (R13), (R14) & (2000), Proe Wildfire4; MicroSoft Office 2007 – Excel and Word.

Industrial Engineering classes at Maynard Industrial Engineering Institute in Columbus,

Ohio.

References: Furnished on request.

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