TAO JIE

Experience: 20 years working Experience in Manufacturing Industry.

Star Array Pte Ltd (Y2022 – Present)

Senior Manufacturing Engineer III

• Set up ISO13485 certified manufacturing facilities for medical instruments. Designing and drawing the manufacturing layouts.
• Production Line set up and training.
• Product transfer from R&D to production, NPI project. 
• Create Process Management Plans. Work with R&D to create dFMEA, and pFMEA.
• Create process control documents such as drawings, BOM creation, and maintenance. Routings, Equipment, tools preventive maintenance calibration (Xtrak) with suppliers (MPC) and troubleshooting. Process specification.
• Established and documented Working Instructions, test instructions and procedures. 
• Review Product design for manufacturability. 
• Knowledge of Manufacturing processes such as PCBA, wire-harness, cables, connectors, power suppliers, plastic molded parts, stamping die casting, sheet metal parts, machining, Surface treatment and the related tooling jig & fixture. Working closely with the vendors to resolve project-related issues.
• Qualify parts for production use. Liaise with suppliers on all quality issues.
• Work with suppliers to generate packaging design and pass TUV drop and vibration test.
• Work with UL engineers to get safety test certification.
• Continuous improvements, use of DMAIC, Root Cause Analyses, Fish Bone Diagram. 
• Work with suppliers to Setup SAP Business One system.
• Working optimally with a diverse cross-functional team.
• Design Cartridge for superfast qPCR using Solidworks. 

Bio-Rad Laboratories (Singapore) Pte Ltd (Y2019 – Y2022)

Manufacturing Mechanical Engineer II

• Working closely with the vendors to resolve project related issues of plastic molded parts, stamping die casting, machining, Surface treatment, sheet metal parts and the related tooling jig & fixture.
• Plan and execute cost reduction, process enhancement, material and engineering evaluation project to achieve cost and operation effectiveness.
• Provide Sustaining Engineering support such as improving manufacturing First Pass Yield (FPY), support manufacturing process improvement and evaluating alternate parts for End of Life (EOL) replacement.
• Support New Product Introduction (NPI) and product transfers from R&D and Contract Manufacturer (CM).
• Provide Product Engineering support such as second level failure analysis, and cost reduction through value engineering activity.
• Plan and ensure smooth startup of new product transfers to local manufacturing operation. Provide product sustaining support after completion of manufacturing transfer.
• Plan and execute engineering activities to improve manufacturing operation key performance indicators such as quality, waste, efficiency and efficacy.
• Plan and execute validation activities to support NPI and product transfer to local manufacturing operation.
• Maintain and ensure systems and procedures are in compliance with ISO, Regulatory and housekeeping requirements.
• Work cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products.
• Product Transfer – New or existing products from oversea.
• Production Line Set Up, Line Balancing, Training for operator and technician. 
• Achieve Manufacturing First Pass Test Yield targets
• Manage Engineering Changes and Qualification
• Implement Continuous Process Improvement projects
• Perform Failure Analysis and implement corrective and/or preventive measures.
• Definition of Procedures, Working instructions and Documents
• Preventive Maintenance / Calibration (Xtrak software) lead a Tools and equipment calibration team work closely with supplier. 
• Coordinate and arrange shipment of tools and equipment in the division
• Ensure tools delivered on-site or returned to vendor do not have any 
• discrepancies. Examples: Missing parts, dents, cracks, etc
• Review customer return disposition and create relevant documentation. 
• Manage Engineering Changes and Qualification
• Implement Continuous Process Improvement Projects
• Review Product Design for Manufacture, Availability and Quality
• Create Process Management Plan and managing engineering change requests/orders
• Knowledge of SAP, ISO13485 requirements, MDSAP, Risk management, FMEA, Lean Manufacturing, 5S. 

ThermoFisher Scientific (Y2015 – Y2019)

Manufacturing Mechanical Engineer II

• Cost reduction projects, Practical Process Improvement (PPI) and VAVE (Value Analysis & Value Engineering) resulted into savings of more than $1 million.
• Worked with both local and global manufacturing partners, cross-functional design teams for the localization of hundreds of parts coming from USA.
• As an in-charge, successfully completed the qualification of PGM (Personal Genome Machine), PGM DX, Ion Chef, iBright Imaging Systems, Attune Flow Cytometry and Proflex, MiniAmp thermal cycler, MiniAmp plus thermal cycler.
• Product design and improvements together with performance verification & validation plan and report.
• Jigs and fixture design and qualification for assembly of instruments using Solidworks.
• Working closely with the vendors to resolve project related issues of plastic molded parts, stamping die casting, machining, Surface treatment, sheet metal parts and the related tooling jig & fixture.
• Hands on experience on creating Work Instructions together with ECR (Engineering Change Request), ECO (Engineering Change Order) ECN (Engineering Change Notice) on PLM & ERP systems.
• pFMEA and BOM creation in PLM (Agile).
• IQ OQ PQ for Higher Level Assemblies (HLA).
• Troubleshooting of injection molded parts at supplier site.
• Solving day to day issues with biomedical instruments being manufactured in-house.
• Success NPI product transfer, iBright Imaging Systems, Ionchef, MiniAmp thermal cycler, MiniAmp plus thermal cycler from R&D to production. 
•  

Main Responsibilities:

• Responsible for product and manufacturing operation process throughout product life cycle. Lead and provide engineering support and solution for sustaining production. 
• Support New Product Introduction (NPI) and product transfers from R&D and other manufacturing sites.
• Plan and ensure smooth startup of new product transfers to local manufacturing operation. Own and sustain the product after completion of manufacturing transfer.
• Plan and execute process validation activities to support NPI and product transfer to local manufacturing operation.
• Provide Product Engineering support such as second level failure analysis, cost reduction through value engineering activity, and Higher-Level Assembly (HLA) outsourcing. Problem solving use of DMAIC, pFMEA, Fish-bone diagram. 
• Set up and maintain Bill of materials (BOM) and drawings in SAP, and manage changes through Agile.
• Develop and maintain instrument/subsystem test station for production.
• Provide Sustaining Engineering support such as improving manufacturing First Pass Yield (FPY), support manufacturing process improvement and evaluating alternate parts for End of Life (EOL) replacement.
• Maintain and ensure systems and procedures are in compliance with ISO13485 and Regulatory requirements.
• Camstar Project. Setup Camstar system and Train technicians using Camstar system. 

Emerson Process Management Asia Pacific Pte Ltd (Y2014 – Y2015)

Product Engineer

· Responsibility for Core FIELD instrument and accessories product family.

Specifically responsible for core products support, design improvement

and test develop technical solutions to production, identify and implement

cost reduction opportunities to follow through with implementation of

design improvements into production.

· Troubleshoot core product and manufacturing process concerning

mechanical assemblies. Interact with supplier base for die cast, plastic,

stamped, machined and similar processes to maintain quality, delivery

and optimal design for manufacturing standards. Using Creo element

direct modeling software to do 3D modeling and 2D drafting. 

· Prepare test plans, test fixture design and test setup in Lab for product

performance testing and write test report. 

· Assume overall project and product responsibility for engineering

documentation maintenance, including drawings, bill of material

specifications, part number setup information and general specifications.

· Provide technical product support and expertise to manufacturing, sales,

marketing and customers.

· Ensured there are no instruments’ leakage under various temperature.

conditions through design, improvement and testing. Using gaskets, O

ring, sealants, Dow corning, and potting processes. 

Venture Corporation Limited (Univac Precision Engineering Pte Ltd) (Y2009 – Y2014)

Product Design Engineer

Design, develop and sketch minilance, Baby heel, and Biohazard Disposal Box and system lancet medical devices for hospital usages and help our customers such as Medtronic, BD, Venture, Illumina, CORIOX, Covidien, PMI and so on design and modify products. Manage the product drawing release and write engineering reports, work closely with mold design department support and give suggestions to mold designers, review DFM. Design tipping, flanging process and fixtures design, DOE. Liaises and suppliers, Engineering BOM creation through to production and ECO. Using Solidworks 2013 and NX7.5 Software. Do motion and force simulations using Solidworks.

Main Responsibilities

1. Meeting with clients to establish the design brief, including the concept, performance and production criteria; 
2. Brainstorming/problem solving as part of a team or developing design concepts human factor consideration using CAD; 
3. Taking part in specialist or multidisciplinary team meetings; 
4. Identifying the suitability and availability of materials; 
5. Producing detailed, final hand drawings and specifications or, more likely, using dedicated computer software (CAD) to produce design specifications, including parts lists and costing; 
6. Making samples or working models by hand or using computerized prototyping equipment. 
7. Testing the design concept by computerized modeling or physical hands-on testing of models; 
8. Researching materials, processes or market requirements. 
9. Arranging meetings and liaising with engineers and other departments, including marketing, to discuss and negotiate appropriate production processes, costs and commercial issues.