Mechanical Engineer Engineering

Terry L. Byler

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

Murrieta, Ca. 92562

Cell #951-***-****

E-mail – ********@*****.***

Professional Objective

Seeking employment in a progressive Medical Device Company so that my skills and experience can contribute to the company's success.

Summary of Qualifications

Mechanical Engineering, Process Engineering, Process Development, Manufacturing Engineering, Industrial Engineering, Product Development and R&D of Disposable, Implantable and Electro-mechanical Medical Devices such as :

Cardiopulmonary & Cardiovascular Devices Infusion Pumps

Blood Monitoring Systems Heart Valves

Catheters (Diagnostic and Treatment) Kidney Dialysis Machines

Stents and Stent Delivery Systems Electronic Hearing Prosthesis

Blood & Chemical Process Separation Systems pH Heart Monitoring Devices

Skills

In Mechanical Engineering of Class I, II, III medical devices.

Performing validations, verifications, qualifications, IQ's, OQ's, PQ's.

Designing and implementing production tooling, fixtures and test equipment.

Working with outside suppliers in the procurement of materials and equipment.

I possess knowledge and understand the use of the latest medical grade adhesive, plastics, metals, surface treating, packaging machines, leak testers.

Injection mold and over mold experience.

Designed, fabricated and implemented semi-automation technologies and QA and R&D electro-mechanical test equipment.

Can use mills, lathes, drill presses plus other machines in a typical machine shop.

Experienced with ultrasonic welding, electronic test equipment Scopes, DVM, etc.

I have experience in Solid Works, Microsoft Word, Excel, Microsoft Project.

Work Experience Pg. 2

6-17 to present Swift Health Systems

Mechanical Engineer

Supported R&D, Manufacturing Engineering, Process Engineering and Electronic Engineering of a class 1 orthodontic device. Required to perform design qualifications, validations, IQ's, OQ's and PQ's. Responsible for manufacturing and process development. I also assisted R&D in the design and fabrication of prototypes, testing equipment, data acquisition, process development, product development and technical marketing.

2-10 to 3-17 Fresenius Medical Care

Mechanical Engineer

Supported R&D, Manufacturing Engineering and Electronic Engineering of a Portable Kidney Machine. Required to perform design qualifications, validations, IQ's, OQ's and PQ's. Responsible for manufacturing processes that included machine and disposable manifold tube sets. I also assisted R&D in the design and fabrication of prototypes, testing equipment, data acquisition, process development, product development and technical marketing.

5-06 to 10-09 Arbor Surgical Technologies Inc.

Mechanical Engineer

Mechanical Engineer of Bio-prosthesis Heart Valve. Required to perform design qualifications, validations, IQ's, OQ's, and PQ's. Responsible for manufacturing processes that included nitinol processing, valve assembly and testing using ALT, Fatigue and Forward Flow machines. I also assisted R&D in the design and fabrication of prototypes, testing equipment, data acquisition, process development and product development.

5-04 to 5-06 ICU Medical Inc.

Mechanical Engineer

Mechanical Engineer of high volume IV sets and related support devices. Required to perform design qualifications, validations, IQ's, OQ's and PQ's.

Responsible for manufacturing processes that included the designing and fabrication of all related tooling, fixtures and assembly aids. Assisted R&D in the design and fabrication of prototypes, pilot runs and protocol testing.

More work history upon request.

Pg. 3

At Fresenius Medical Care I designed, fabricated, implemented, and wrote a patent:

‘Smart Actuator Valve”

Pub. No. : US2015/0129055 A1

Pub. Date: May 14, 2015

Educational Background

Cable Wire Systems Networks 1976 to 1980

Fort Gordon Signal School, Ga.

Electronic Engineering Design 1976 to 1980

Central Texas College, Killeen, Tx.

Electronic Engineering Design 1983 to 1985

I.T.T. Technical Institute, Buena Park, Ca.

Computer Repair 1986 to 1988

Coastline Community College

Huntington Beach, Ca.

Short Summary of Medical Devices that I helped take to Market

Catheters :

Guide Introducer Catheter

PTCA Retroperfusion Catheter

Adherent Clot Neuroperfusion Catheter

Graft Thrombectomy IV Catheter

Embolectomy Infusion Catheter

Vessel Calibrators Diagnostic Catheter

Disposable Devices :

Wound Drainage Blood Transfusion

Inflation Devices Dialyzers

Heat Exchangers Blood Filters

Oxygenators Blood Separators

Drainage Tubing Sets Hemoconcentrators

Prime Lines Bubble Traps

Implantable Medical Devices :

Heart Valves Vibrent Sound Bridge

Arterial Grafts Venous Placement Catheter

Micro Stents

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