Stephen Lee Yung Chin, Pmp® Email and Phone Number

* Manage a group of work stream leader and project lead taking care of production line transfer project and NPI projects. Ensure the project leads are managing the engineers and project team members well in delivering the project goal as per committed timeline.* Coordinate and host project update meeting with top management, internal&external team and various stakeholders. Develop tracking files and action plans to ensure projects are well communicated among the cross functional team.* Set direction and monitor strategic manufacturing department metrics, tasks and priorities based on project timeline, quality, scope and financial requirements. Drives the team to meet these requirements to ensure project goals and objective are met.* Builds relationships / networking with counterparts worldwide to ensure flawless execution of projects.

* Take the lead role in Greenfield production line transfer project, engineering yield improvements project and improvement of equipment health and maintenances. * Overall lead and manage the manufacturing engineering team. Apply engineering principles to the planning, design, manufacturing process qualification and validation, documentation and testing of medical device/products. Development of Design of Experiments (DOE), Statistical Process Controls (SPC), process Failure Mode & Effect Analysis (pFMEA) and process characterizations.* Coordinate and host project update meeting with top management, internal and external team. Develop tracking files and action plans to ensure projects are well communicated among the cross functional team.* Drive continuous process improvements activities utilizing lean manufacturing principles and six sigma; including conducting root cause analysis and lead Corrective Action Preventive Action (CAPA) investigations.* Set direction and monitor engineering department metrics, tasks and priorities based on manufacturing engineering, quality and financial requirements. Drives the team to meet these requirements to ensure compliance to plant goals and objectives which includes process health, maintenance, calibration, costs, staffing and production schedules. * Builds relationships / networking with counterparts at the worldwide manufacturing facilities. Key Achievements:* Completed production and technology transfer project in top multinational company. Lead the line setup and commissioning activities as per the schedule, within the budget and meeting quality expectations.* Manage a diversified team consists of 18 engineers and technicians in a green field plant and lean organisation.* Coordinated audit preparations activities within engineering team with no findings from regulatory bodies.* Excelled in GMP, GDP, ISO 13485 and FDA 21 CFR Part 820 compliance environment.

Work Description :* Take the lead role in NPI, improvement and production line transfer project management. Ensure project are on schedule, meeting quality requirements with statistical analysis as well as within budget. * Be the overall leader for project charter review, project risk analysis, change control review, URS review, process FMEA, RD design review, manufacturing review and SOP review. * In charge of new project feasibility study, gathering of project technical information, study ROI / suitability as well as preparing presentation slides and project paper to present in the meeting with top management.EXPERIENCES GAINED:* Work in GMP, GDP, ISO 13485 and FDA 21 CFR Part 820 compliance environment. * Familiar with medical validation procedures and requirements.* Have experience to work with cross-functional team in big medical manufacturing organisation.* Enhancement of report writing, presentation and communication skill.* Knowledge in medical process work flow.* Proven initiative and ability to work with minimum supervisionProjects involved & handled:1. Ecoflac & Dosifix line transfer project to Vietnam.2. New pen needle production line and capacity expansion project.3. Pen Needle line LE improvement project - sealing station.4. Pen Needle NPI project - New Omnican Glued Version.5. Pen needle NPI project - New G31 x 4mm product.6. Pen needle NPI project - New G31 x 5mm product.7. Pen needle NPI project - Pencylcap G29 x 12mm.8. Pen needle NPI project - New short shield implementation.9. Pen needle improvement project - New needle based injection system hub thread.10. Pen needle ISO compliance project - Medical grade silicone oil project.11. Pen needle improvement project - Extra thin wall and flow rate improvement project.12. Pen needle improvement project - Serofine primary improvement.13. Molding - New Primary container mold and injection molding machine project.14. Molding - New glued hub mold project.

Work Description :* Take the lead role in latest projects management for the whole GROUP. Ensure all the new projects are on schedule and within budget. * Become the main contact point for all technical issues which involve outsiders /foreign consultants. Provide engineering and technical support to subsidiaries within the group. * Conduct the technical and engineering training session to production plants if there is any latest technical knowledge which is essential.Projects handled: 1. New product development / product diversification project (a) Work with sales & marketing department to identify customer feedback on new product requirement. (b) Work with external equipment consultant on possible machine modification required in order to test run the new / modified product. (c) Conduct product trial run and testing with production team. 2. New production line & production plant setup project(a) Approach MIDA to apply the manufacturing licence, tax incentives and expatriate post applications. (b) Liaise with local authority / government, surveyors and geotechnical experts on land purchase, boundary & topography survey, soil investigation and building plan approval. Meet with architect and EIA consultant on the proposed project. (c) Draw the preliminary plant layout, study the incoming raw material and outgoing finish goods process flow and setup new production line configuration & design together with production team. (d) Obtain quotation from different supplier and make throughout technical analysis as well as price comparison for new factory building construction, machine foundation and equipment installation. (e) Meeting and discuss with equipment supplier on equipment specification. Work with legal team to study and verify the equipment sale & purchase contract. (f) Meeting with feasibility study consultant, legal consultant and factory property insurance agent in mitigating project investment risk.

Work Description : * Take the lead role in NX (Unigraphics) CAD technical support in Northern region. * Solve customer mechanical design and software bugs problem as well as involve in mechanical 3D design using CAD design software. * Provide CAD application support in sheet metal, molding and free form modeling. * Prepare CRM report to cut down problem solving time and understand the root cause of design problem. * Conduct the technical and engineering demonstration session. * Conduct training for new CAD user/customer. EXPERIENCES GAINED:* Mechanical Computer Aided Design (CAD) modeling, drafting and assembly application.* Technical problem solving and analytical skill.* Enhancement of presentation and communication skill.* Proven initiative and ability to work with minimum supervision.* Pass the designer test and obtained the Professional Designer Certificate from Siemens PLM, USA.* Handled 100attendees product demo/presentation event.