Engineer Project

JIM S. GAN

**** **** ***** ***, *********, CA ***56

949-***-****, (Email) *************@***.***

PROFESSIONAL HIGHLIGHTS

. Mechanical Engineer with hands-on electromechanical design, manufacturing

support, and process engineering

experience

. Demonstrated success in design, analysis, simulation, trouble-shooting,

and providing engineering solutions

. Subcontract management and project management experience in global

business environment

. Proficient at balancing technical cost, schedule, and programmatic

elements of a project

. Effective communication skills with all levels of personnel from senior

management to production workers

PROFESSIONAL EXPERIENCE AND ACHIEVEMENTS

Beckman Coulter, Inc., Carlsbad, CA

March, 2008 - Present

Sr. Technical Operation Engineer --Engineering Group

. Conducted engineering feasibility studies for the cap design including

the capping and induction sealing process. Assisted suppliers to

investigate the root causes of product quality related issues; provided

technical expertise to mitigate the problems. Designed a multifunctional

working station for the packaging assembly line. Designed filter-housing

fixtures to streamline the production process, and to shorten the change

over times. Designed and fabricated a CIP system to improve the lab

cassette cleaning process, and re-engineered a dialysis pump fixture to

improve the production safety and to increase the production yields.

Assisted validation engineers to execute the SAT and FAT protocols.

. Effectively managed a $2.5M Isoton 10X project from preliminary

formulation/purified water system design to generate the User Requirement

Specifications. Sourced, selected, and negotiated contracts with

vendors, oversaw the construction, provided inputs for the FAT, SAT, and

assisted to solve some validation related issues.

. Successfully managed and coordinated a $2M facility consolidation project

from relocating the equipment to implementing the new production process;

responsible for procuring new equipment, designing the new manufacturing

and lab environment/space, overseeing the construction, and assisting the

final validation process.

B. Braun Medical, Inc. Irvine, CA

2006-2007

Automation Engineer (Contract)--Plastic Irrigation Container Group

. Supported Blow Molding plastic bottle improvement, successfully

accomplished a six-year old project by identifying and redesigning mold

plates to test/qualify new bottles.

. Coordinated capital projects between each department and customers;

provided expertise in revising BOMs, programming Bar Code/printing

systems, and conducting design reviews.

. Designed critical mechanical fixtures and parts to improve ongoing

manufacturing process and to increase production efficiency. Provided

support to the validation group during the PQ process.

. Studied and re-designed the cooling/heating system on the existing

production equipment by adding new elements to re-adjust the flow rates

on a timely fashion to increase the production yields.

Robinson Pharma. Santa Ana, CA

2006-2006

Manufacturing/Project Engineer (Contract)--Core Engineering Group

. Responsible for design and implementation of manufacturing process

improvements. Updated encapsulation, packaging, and tablet equipment to

meet industry standards; documented and improved manufacturing procedures

and standards to substantially improve product yields and manufacturing

efficiency. Supported process validation group.

. Designed and oversaw the completion of a hot water loop system to

maintain product containers in a stable working condition.

Advanced Medical Optics (AMO). Santa Ana, CA

2005-2005

Project Engineer--Surgical R&D Group

. Utilized SolidWorks 3D modeling software to design automated dip/spin

equipment used to study lubricious cartridge coating delivery unit

including an automated drying system.

. Responsible for design, test development, data analysis, vendor selection

and subcontractor management.

1. Worked closely with customers and research scientist to implement major

fixtures and develop new testing methods, which improved the

manufacturing process.

Trimedyne Inc., Irvine, CA

2004-2005

R & D Engineer--Surgical Laser R&D Group

. Utilized SolidWorks 3D modeling to design and prototype a fiber optic

delivery surgical device to support production.

2. Managed the project from design, test, assembly drawing preparation,

production fixture setup, and transfer the project from R&D to the

manufacturing production lines (Transition effort included verifying test

results and authorizing release of manufacturing process and procedures).

Edwards Lifesciences, Irvine, CA

2001-2003

Senior Engineer--Cardiovascular Research Group

3. Oversaw engineering efforts to support PTFE graft manufacturing process;

managed projects between manufacturing and R&D groups through design,

test, validation, training, and implementation.

4. Led team to investigate the root cause of product defects;

established/implemented the corrective action to prevent recurrence.

5. Revised/implemented maintenance procedures to cut equipment downtime

from 900 to only 300 hours Per year, (This effort increased production

rate by 35% while cutting overtime by 80%).

6. Utilized ProE 3-D modeling software to design critical mechanical parts

and manufacturing components to increase production efficiency and yields

(tasks included drawing review, rapid prototype/refine, data

analysis/validation, and first article inspection).

7. Managed subcontractors; provided technical oversight to ensure

completion of quality products on time and within budget.

8. Conducted independent research and analysis to optimize product-

packaging quality to guarantee a 99.9% sealing reliability. Performed

engineering study to generate data to support validation process.

9. Researched/designed high-frequency vibration systems to remove implant

products from production equipment (This effort increased product yields

by 40%).

Banner Pharmacaps, Chatsworth, CA

1996-2001

Process Engineer--Technical Service Support Group

. Led a team to identify and revamp the inspection and packaging process by

using vacuum transfer technology; activity included reviewing,

prototyping, refining of the study and repetitive testing of a vibration

holding system.

. This new process utilized existing equipment to reduce repetitive

handling motion by 90%; result was a significant reduction in worker's

compensation claims.

10. Implemented automated data collection software to monitor in-plant

processes (designed and fabricated a system, including selections of

temperature/humidity transducers, valves, level sensors, I/O modules,

power supplies and other components to collect manufacturing data and to

provide information regarding equipment usage, material forecasts,

process control, and detection of equipment malfunction). Assisted the

validation engineer to complete the validation process for the system.

Fibersteel Industries, Greenville, SC

1992-1996

Design Engineer--Technology System Group

11. Collaborated with engineers, sales representatives, suppliers, and

clients to establish a $1.5M fiberglass tape production line in Beijing,

China (traveled extensively to manufacturing site to coordinate the

project and to provide technical support from the proposal phase through

the final completion and production).

12. Designed and implemented laser sensors on tape-cutting tools to reduce

raw material waste and simplify operating procedures.

EDUCATION

B.S. Mechanical & Aerospace Engineering, Rutgers University, College of

Engineering, New Brunswick, NJ

PROFESSIONAL & TECHNICAL DEVELOPMENT/AFFILIATIONS

1. Engineer-In-Training, California License No. XE08936

2. Member: ISPE, ASME

3. AutoCad to version 2000 (10,000 hrs), SolidWorks (10,000 hrs), ProE

(4,000 hrs), VersaCad, InterGraph

4. MS Office (Word, Excel, Powerpoint), Intellution Software, Visual Basic

and Fortran 77

5. Conversant in Chinese (Mandarin)

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