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Mechanical Engineer Medical Device

Rowland Heights, California, 91748, United States
June 09, 2019

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***** ****** **. ******* *******, CA 91748 Cell Phone 626-***-****


Proven background in Mechanical Engineer, Manufacturing Engineer and Software Engineer

Strong knowledge of Hydraulic, Pneumatics, Packaging, Medical device, Sheet metal, Quality control, and Chemical (included Pharmaceuticals, Plastic -- included Extrusion and Thermoforming) Equipment

Supervisory experience with engineers in, Pharmaceutical Packaging department operations (included Plastic Thermoforming Process), Medical Device Project, and Plastic Extrusion Manufacturing

Extensive experience with Process Development and Database Technology

Excellent AutoCAD, Inventor, Solid Works, Pro/Engineer, CREO2.0, UG NX 6.0, CNC, ANSYS, LabVIEW, VB, PLC, PowerPoint, skills


Mechanical Engineering Instructor (contract)

HeiBie Technology Institute. YanJing, China 01/2016 to 08/2017 06/2015 to 08/2015 01/2014 to 06/2014

Taught "Manufacturing Processing Development" course for Sr. level mechanical engineering students

Analyzed and designed the manufacturing process layout, reduce cost and quality control

Analyzed and developed processing development model

Consultant Engineer (1 month contract)

Edward Lifesciences. Irvine, CA 10/2015 to 11/2015

Analyze the medic device extrusion manufacturing data and create specification parameter

Compile the medic device extrusion manufacturing Validation Reports

Test Engineer (contract)

HP (RLA Engineering LLC), Vancouver, WA 02/2015 to 04/2015

Development of test plans, verify testing process, and analyze the root cause

Design testing tools, testing procedure and quality control

Manufacturing Engineer

BIT Group US. San Diego, CA 08/2014 to 12/2014

Create and design the medical device assembly procedure and assembly tools

Design the Medical device manufacturing transfer quality control and manufacturing layout

Create Onyx Assembly User Guide

Mechanical Engineer (Project Team Leader)

Beijing WHPM Inc. Beijing, China 12/2012 to 07/2013

Research, develop, implement, and support pharmaceutical manufacturing processes

Recreated Loot Number System (It can increase over 5.2 % efficiency)

Quality control and troubleshooting technical problems

Research and design AFOB medical measurement equipment

Create and perform the validation (IQ, OQ and PQ) for new packaging product line (included thermoforming process that produce plastic packaging containers for medic device)

Manufacturing Engineer (shift leader)

SpireTek Int. Inc. Port Lavaca, TX 12/2010 to 06/2012

Supervise technicians, operators and manage shift product lines (extrude the PVC foam to construct products)

Research, develop, and support PVC foam extrusion manufacturing process

Create and edit the PVC foam extrusion production line’s SOC & SOP

Production quality control and troubleshooting technical problems

Mechanical Engineer (Team Leader)

Amphastar Pharmaceuticals Inc., Los Angeles, CA 1/2007 to 05/2009

Supervise several engineers and technicians at packaging department

Troubleshooting problems and improving manufacturing processes (included thermoforming process that produce the plastic packaging containers for Pharmaceutical product)

Gathers operational, test data and evaluates results; takes corrective actions

Packaging product line’s validation (IQ, OQ and PQ)

Programmer Analyst

Automatic Data Processing Inc., Portland, OR 12/1998 to 04/2005

Analyzed and designed the new programs to create A.D.P. standard data from manufacturer data

Modified existing programs, created documentation and answered questions to product analysts

Did troubleshooting technical problems and debugged code as well as PM, TMM.

Mechanical Engineer - Zess Technologies, Inc., Portland, OR 06/1998 to 12/1998

Designed and developed HVAC equipment and testing processes

Developed and analyzes test data to determine scope of testing support (testing processes)

Developer Engineer - DongFang Computer Data Inc., Beijing, China 06/1994 to 01/1997

Led several programmers for the analysis, design, and development in database group

Created program specifications, application documentation, and troubleshooting problems

Mechanical Engineer - Beijing General Industries Corp., Beijing, China 09/1984 to 05/1989

Created, and updated manufacturing processes and methods for components and mechanical assemblies

Performed tests for the mechanical components, fixtures, and manufacturing processes

Sheet metal cabinet design (included Sheet metal drawings and CNC program)


Root Cause Analyze (Test engineer) – HP (RLA Engineering LLC)

Evaluate testing results and verify testing method, submit the product improvement recommendation to HP design team.

Automated FOB (Fecal Occult Blood) Medical Device. (Chief engineer, team header) – Beijing WHPM

The AFOB device is a high effect and high reliable testing measurement (UDI & capture system, Process control system, Vision systems, OP and database system and Structure design)

The project included: project proposal, concept design and project specifications, create project team at Beijing, China, systems design, parts design, compute program design (using C#, SQL, PLC, CREO 2.0, CNC)

Laser Thickness Measurement Equipment Project – PVC (SpireTek Int. Inc.)

Designed and set up laser thickness measurement equipment for extrusion PVC foam production lines, which can test thickness and reduce over 35% scrap (reduce the extrusion PVC foam product line’s set up time from 6-9 hours to about 45 min and improve the quality). Accomplishment: Saved $2.5 million to $4 million for PVC / year when the project finished. The project include: project proposal created, project specifications and concept design, testing structure design, computer program design, alarm system design, and bills of materials

Packaging Product Line’s Validation (IQ, OQ and PQ) – Beijing WHPM Inc.

Pharmaceutical packaging product line’s factory acceptance testing

The project included: analyzes design specifications and created test specifications; design testing procedures and edited testing plan; established quality control value for processing; created IQ, OQ, PQ menus and performed them; document the validation report (included thermoforming process that produce packaging containers for medic device).

Job Submission Project (System Project) (Chief Designer) – A.D.P.

Developed an IBM mainframe based system that included 10 screens, 37 subprograms, multiple processing tables, and documentation. Users can use multiple screens to maintain data from different manufacturers- Controls the IBM to do the product run or maintenance copy for different manufacture data. Linked IBM, LTG library, Tape library, User library, Control table, log file and printers. It created JCL, roadmap, labels, QA report, and sent the processing message to the log file.


Redesign loot number system project for medical device manufacturing (It can increase over 5.2 % efficiency)

Design temperature control system for extrusion PVC foam production lines (Improve quality and reduce 3% - 5% scrap)

Compile the extrusion manufacturing line specification and edit the process validation reports (Medic device)

Evaluate and develop new machine for PVC foam extrusion manufacturing


Portland State University, Portland, Oregon. Graduate

M.S., Mechanical Engineering.

Wayne State College, Wayne, NE. Graduate

B.S., Computer Science.

Beijing Chemical Engineering University. Beijing, China. Graduate

B.S., Chemical and Mechanical Engineering.

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