Engineer Medical Device

JOHN V. CARLSON

*** ******** ***** ******, **. Michael, MN 55376

763-***-**** ? **********@*******.***

ENGINEERING PROFESSIONAL

MANUFACTURING ? INDUSTRIAL ? PROCESS DEVELOPMENT

Accomplished engineering professional with significant experience in the

medical device industry. Skilled in staff supervision, cost control,

process design/improvement and technical solutions.

. New product development leadership demonstrated on process

development, production machine design, equipment qualifications

and process validations.

. Designed and developed fixtures and processes to enhance

manufacturability and capability using DOE and Lean Manufacturing

techniques.

. Expert in systems/process design, cost-reduction strategies and

quality improvements.

. Known for innovative problem solving, complex troubleshooting and

skillful relationship-building with national client staff and

teams.

PROFESSIONAL EXPERIENCE

Independent Engineering Consultant

2009 to Present

Providing support engineering for a renewable rigid urethane foam

system for a start-up company.

Nanocopoeia, Inc., St. Paul, MN 2004 to 2009

Nanocopoeia is a start-up company with a proprietary technology

to formulate and apply nanoscale drugs, polymers and other

material coatings onto a variety of surfaces for the purpose of

controlled therapeutic delivery.

Process Development Engineer

. Co-invented process for coating medical devices using

nanoparticles. Application for patent is currently under review

with the United States Patent and Trademark Office.

. Managed spray equipment design, fabrication, qualification

and maintenance.

. Designed, managed fabrication and trained personnel to operate

first generation ElectroNanospray equipment to coat medical

devices.

. Developed fixturing and process improvements to coat drug

eluding stents for a Phase l Small Business Innovation Research

(SBIR) grant.

. Implemented equipment design improvements to enhance the next

generation ElectroNanospray machines for a Phase II SBIR grant.

. Managed equipment scale up to ensure manufacturing

commercialization goals for coating drug eluding stents.

. Characterized and qualified fixturing and process parameters to

coat a miniature (mouse) stent used in therapeutic testing with

various polymer and drug coating ratios.

Raymedica, Inc., Bloomington, MN 1999 to 2004

Manufacturing Manager (2003-2004)

. Promoted in 2003, provided supervision for one manufacturing

engineer and three assemblers in addition to performing

engineering duties.

Principle Manufacturing Engineer (1999-2003)

. Provided operational support for an implantable medical device.

. Managed the design, fabrication, training, maintenance and

process validation of new tooling and production equipment for

weave cutting, molding, solvent exchange, wire insert, heat

sealing and flattening processes.

Raymedica, Inc. - cont.

. Increased production output volumes from 50 to 1200 units/month

in three years.

. Improved production yields from less than 40% to greater than

80% in two years through

long-term corrective actions.

. Qualification of Ransohoff Lean-Jet Rotary Basket Washer using

IQ, OQ and PQ.

. Coordinated $200,000 facilities expansion project that doubled

the office space, engineering lab and manufacturing areas for

staff growth.

American Medical Systems Inc., Minnetonka, MN 1997 to 1999

Senior Industrial Engineer/Senior Manufacturing Engineer

. Responsible for the layout and facilities project management for

a 180,000 sq. ft. medical device manufacturing facility.

. Evaluated warehouse operation and improved order picking

efficiency by 23%.

. Redesigned packaging area to improve product flow, minimize

labeling errors and reduce work injuries related to repetitive

trauma.

Schneider Worldwide Inc., Plymouth, MN 1987 to 1997

Senior Industrial Engineer

. Core member of a process development team to enhance the guiding

catheter production process lines.

. Core member of an implementation team to convert production

lines to Demand Flow, increasing productivity by 52% with a

yield increase of 11%.

. Managed the layout of manufacturing areas, machine shop, labs,

warehouse and move coordination to a new 200,000 sq. ft.

facility including a 20,000 sq. ft. controlled environment.

. Designed and executed distinct production lines for five new

diagnostic and guide catheter production lines.

. Designed processes to improve quality, reduce labor, improve

safety and ergonomics.

. Developed standards, bills of material and routings for

diagnostic, guide and balloon catheter product lines.

EDUCATION

B.S. Industrial Engineering, North Dakota State University, Fargo,

ND

CONTINUING STUDIES

. Six Sigma Green Belt Certification - Sixsigma.us

. SolidWorks CAD Training - Hennepin Technical College, Brooklyn

Park, MN

. Lean Flow Certification for Manufacturing - St. Paul College,

St. Paul, MN

. Design of Experiments Workshops - Stat-Ease Inc., Minneapolis,

MN

. AutoCAD Training - Hennepin Technical College, Brooklyn Park, MN

. Demand Flow Technology Workshops - Demand Flow Institute,

Denver, CO

. Just-In-Time for America Training - Handley-Walker Company

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