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Project Manager Engineer

Location:
San Jose, California, 95120, United States
Posted:
May 24, 2010

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Steven N. Shortt

**** ******* *****

San Jose, CA 95120

E-mail: abmrnp@r.postjobfree.com

(408) ***-**** (Cell)

(408) ***-**** (Hm)

Career Objective: Project Manager for the development of high volume

automation equipment and tooling used for Manufacturing in the medical

industry. Over see all phases from concept to final installation of

equipment.

Areas of Focus:

. Project Management of Small Fast Development Teams

. 11 years of experience in High Volume Automation

. Automation Design Engineering

. Class 2 Medical Instrumentation Design

. Mechanical Design (Fixtures, Tooling and Instruments)

. Hazard/Risk Analysis/pFMEA

. Design of Medical Disposables

. Computer/CAD Systems: SolidWorks, Autocad

. Robotic/Automation Installation and Support

. Facilities Layout and Process Flow

. Organize and Facilitate Meetings

. FDA and ISO Requirements

2001-Present

Terumo Medical Corporation (Frozen Blood Processing System and Blood

Separation System) Fremont, CA

Direct competitor to Haemonetics Corporation, COBE Cardiovascular, Inc.,

Terumo Medical Corporation, Pall Medical

Sr. Project Engineer

. Project lead in generating the EQT (Engineering Qualification Testing)

and DVT (Design Verification Testing) plan and execution for the blood

processing equipment

. Generate engineering test protocol and reports for blood processing

equipment

. Chaired design review meetings related to the design, development and

release of the Aphaeresis Kit for commercial use

. Reviewing of engineering drawings for fit, form and function on an

Aphaeresis Kit and plasma/red blood cell disposables

. Responsible for the generation of requirement documentation for the

Aphaeresis Kit and plasma/red blood cell disposables

. Interface with contract manufactures responsible for the transfer of

product for commercial production

. Responsible for assisting in the creation and execution of the IQ, OQ

and PQ at contract manufacture

. Part of a task force responsible for the creation and implementation

of the quality system

. Generated statistical analysis based on testing of glue joints; pull

tests, particulate counts for the Aphaeresis disposable kit.

. Technical Leader responsible for coordinating the build program for

bringing the Frozen Blood Processing System to a state of readiness

for both the In-Vitro and In-Vivo studies

. Managed the manufacturing of the Frozen Blood Processing Disposable

Assemblies using outside contract manufactures

. Responsible for the coordination of biocompatibility and sterilization

validation studies by an outside contractor

. Created project plan, cost analysis, and hired supporting staff for

this $750,000 Frozen Blood Processing System projects

. Identified FDA approved off the shelf hollow fiber technology

bacterial filter and separator, which improved the performance and

consistency for the Frozen Blood Processing System saving the company

$200,000 + in the first 3 months of the project

. Developed 3d working model Frozen Blood Processing System to determine

fit, form and function allowing the company to complete a DFM and

reduce cost of product 50%

. Assisted in the development and implementation of new internal QSR

program required to be in compliance with the FDA

. Engineering responsibilities included completing a tolerance analysis,

load calculations and material selection for DFM

. Development of product specifications, DHF, DMR, DHR, SOP's, W.I.

validation and stability protocols and associated reports in support

of QA/QC functions for compliance to GMP and QSR regulations

. Team member responsible for the required planning and execution

involved with receiving a California Manufacturing License for medical

products

. Assisted in the generation of written requirements and contractual

negotiation for capital equipment

. Generated verification test protocols and reports for the Frozen Blood

Processing System

. Part of a team who created specification and requirement documentation

defining what and how the Frozen Blood Processing System shall operate

1998 - 2001

Amira Medical (Blood Glucose Monitor Manufacturer) Scotts Valley, CA

Direct competitor to LifeScan, Abbott Laboratories, Bayer, Mediscense,

Roche Diagnostics

Automation Engineer/Project Manager

. Project Leader for the in-house design and installation of four

modular test strip converting systems

. Supervised two designer, six E/M technicians and two machinists during

project build

. Wrote equipment specifications, performed detailed planning and

scheduling, budget tracking, price and contract negotiation

. Project Leader responsible for working with outside turnkey automation

vendors, and in-house process engineers on the development of new

equipment for next generation web-handling and chemical delivery

systems

. Responsible for the coordination and execution pFMEA and design review

meetings

. Generated test protocols and reports for test strip automation

equipment

. Working knowledge of hydraulics and pneumatics

. Performed the mechanical engineering and 3d layout design for the

walking beam indexing transports systems, hydraulic die cutting system

and packaging used in the modular converting system to check for fit,

form and function of all parts

. Produced document tolerance studies to insure accuracy of each station

to eliminate handling issues within process

. Design and built tooling fixture and jigs required for accurate

process setups

. Designed, developed, and I/Q, O/Q, and P/Q systems for cold chemical

manufacturing, which extended the life of the chemistry for the

process by 600%

. Implemented product counting system, which improved count reliability

to meet manufacturing requirements and delivered a $400,000 R.O.I. in

6 week

. Implemented and maintained equipment spare parts inventory.

. Managed supplier relationship

. Responsible for assisting in vendor audits

. Negotiated contract terms and conditions on equipment builds with

contract manufacturers

1988-1998

Komag, Incorporated, San Jose, CA

Automation Engineer

. Performed extensive conceptual studies for automation equipment and

tooling

. Developed detailed proposal drawings

. Responsible for the generation of timing studies

. Managed project costs and schedules

. Worked with suppliers to fabricate equipment to Komag specifications

. Coordination of delivery, assembly, testing, installation, burn-in,

and release of new processing equipment

. Designed, developed, and implemented production disk manufacturing

process equipment for 64, 84, 95, and 130 mm disk production line.

. Created standardized saddles, combs and mandrels to handle disks

. Project managed the design, fabrication, and installation of high-

pressure wash systems in Malaysia and US. Worked with turnkey vendor

to replicate 80+ systems over a two-year period and installed in

Malaysia, Sarawak, Japan and US.

. Created facility layouts and processes flow diagrams for automation

equipment world wide

. Supervised general contractor, facilities department, and sub-

contractors during the installation and optimization of manufacturing

. Generated engineering assembly drawings and details of automation

equipment

Education

B.S. Industrial Technology, San Jose State University (1986)

Minor. Business Management, San Jose State University

A.S. Technical Drafting, West Valley Junior College (1983)

Professional Courses

SolidWorks Training Levels 1 - GEI Technology

AutoCAD Training Levels 1, 2 & 3 - Copper Connection & MicroCAD

OSHA Bloodborne Pathogen training

Quality Systems Certification

Material Disposition Training

Quality Systems Management

Transit testing certification (ASTM D4169)

Minitab certification for

. Introduction to Minitab

. Basic Statistics

. Statistical Quality Analysis

. Factorial Designs

Design & Administrative Software Skills

SolidWorks 2006+ (3 years), Autocad Mechanical Desktop (3 years), Autocad

2000 (14 years), MS Office, Visio, Microsoft Project, Minitab and Adobe

Photoshop

Keywords

Robotics, Class 10, Contamination Control, I/Q, O/Q, P/Q, S.O.P., QSR, ISO

9001, Automation, High Vacuum, Sputter, Microsoft



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