Mechanical Engineer Medical Device

BIN (BEN) LIU

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

PROFESSIONAL SUMMARY

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) Equipment

Supervisory experience with engineers in, Pharmaceutical Packaging department operations, Medical Device Project, and Plastic 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

EDUCATION

Portland State University, Portland, Oregon. Graduate

M.S., Mechanical Engineering.

Wayne State College, Wayne, NE. Graduate

B.S., Computer Science.

Beijing University of Chemical Technology. Beijing, China. Graduate

B.S., Chemical and Mechanical Engineering.

Electronics Test Engineering Technician Jabil, Irvine, CA 01/2022 - Present

Setup testing Equipment and Programs

Test PDB, TIB, RMA, PCD

Analyze test data and troubleshooting technical problems

Edit test reports and submit them to different departments

Training several testers

PROFESSIONAL EXPERIENCE (2012 – 2019 Various Contractor Positions)

Consultant Engineer / Contractor Consultant

Edward Lifesciences, Irvine, CA

Analyze the manufacturing data

Create new manufacturing specification parameter

Edit the Manufacturing Validation Reports

Test Engineer / Contractor

HP (RLA Engineering LLC) Vancouver, WA

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

Design testing tools, testing procedure and quality control

Edit test reports and Submit the improvement recommendation report to design team

Manufacturing Engineer / Contractor

BIT Group US. San Diego, CA

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 2012 - 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

Manufacturing Engineer / Shift Lead - SpireTek Int. Inc., Port Lavaca, TX 2010 - 2012

Supervise technicians, operators and manage shift product lines

Research, develop, and support plastic manufacturing processes

Create and edit the plastic production line’s SOC & SOP

Production quality control and troubleshooting technical problems

Mechanical Engineer / Team Lead - Amphastar Pharmaceuticals Inc., Los Angeles, CA 2007 - 2009

Supervise several engineers and technicians at packaging department

Troubleshooting problems and improving manufacturing processes (included thermal modeling)

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 1998 - 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 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 1994 - 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 1984 - 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)

MAJOR PROJECTS

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 production lines, which can test thickness and reduce over 35% scrap. 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 (testing code), alarm system design, and bills of materials

Packaging Product Line’s Validation (IQ, OQ and PQ) – Amphastar Pharmaceuticals 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.

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.

ADDITIONAL PROJECTS

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

Design temperature control system for production lines project (It can reduce 3% - 5% scrap)

Create the manufacturing specification and edit the process validation reports (medical device)

Evaluate and develop new machine for process improvement activities project

Robotics designed project for product measure and packaging (team work)

Piping system layout and design for medical factory (included risk analysis and P&ID)

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