Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Position Summary:

The Process Engineer is responsible for the implementation and maintenance of the manufacturing processes for Thermo Fisher Scientific Suzhou China Factory. This includes activities related to process development, validation, & documentation of new processes, and maintenance of existing processes within plastic consumable products for Thermo Fisher Scientific. Manufacturing processes is including precise injection molding, extrusion blow molding, assembling as well as secondary process.

Essential Job Functions and Accountabilities:

• Lead implementation of new production equipments into production; including plan, order, validate and install production equipment like injection molding machines, assembly lines, process equipments and inline test-machines.
• Define production layout, keep improving the logistical route; Production/injection molding capacity analysis and improvement.
• Responsible for establishing and optimize manufacturing/injection molding processes, methods and procedures to assure product performance, quality and cost effectiveness. Responsibilities include acquisition, implementation and integration of new molding processes, machines and equipment, and materials into production. Establishing and maintaining existing documentation for products and processes. This includes manufacturing specifications, i.e., BOM, routings, set up sheets and other related technical input and documentation. Follow up of ECO changes in production.
• Accountable for safety including adherence to all government requirements and codes on existing and purchased equipment (machines). Responsible to maintain safety compliance based on established procedures. Develops PFEMA analysis for primary processes and new programs.
• Establishes quality requirements, tolerances and specifications. Coordinate and complete the validation process for new molding processes, machines and equipment. Coordinates and directs training for the operation. Reviews, analyzes, directs, and implements improvements to products and processes to assure improved product quality.
• Prepare and keep Work Instructions up-to-date. Work with production lines to provide technical support, troubleshoot existing processes and training for operators. Continuously seek for new manufacturing knowledge and skills.
• Reviews, analyzes, directs, and implements improvements to products and processes to reducing manufacturing & and operational costs through continuous improvement process. Works to develop corrective and preventive actions on systemic problems for processes. Investigates and implements actions for reduction in scrap, improved productivity, and for implementation of cost reductions and improved product quality. Prepares capital appropriation requests and is responsible for administering the approved project capital.
• Leads new introduction or transfer project from engineering workstream, working with project team and global team to completed engineering related tasks in time to well setup the new product manufacturing process in China sites.
• Fully participates in PPI /Lean /TPM with daily Gemba participation & support of production objectives including schedule execution, downtime reduction, troubleshooting, etc. Supports effective Gap teams to drive continuous improvements. Provides technical assistance and expertise to manufacturing in problematic situations, implementing corrective action. Leads kaizens to quickly address opportunities associated with safety, quality, delivery and costs.
• Interfaces with production management, other engineers, set up, operators, etc. to resolve problems, identify needs and implement improvements. Provides training to set up and operators as required.
• Works on special projects as assigned by manager.

• Minimum of Bachelor of Science degree in Plastics or Mechanical Engineering.
• Minimum 10 years' experience in MNC with precise injection molding manufacturing process/engineering with a high propensity toward technical competency.
• Excellent technical skills including demonstrated technical competent and capable of handling all projects within this discipline, organization, and planning. Project management experience is preferred.
• ISO 13485 QMS and clean room manufacturing experience is needed, cGMP or GMP and NMPA regulations experience preferred
• Strong oral & written communication skills in English
• ERP system experience, SAP, or Oracle.
• Demonstrated experience in Lean Manufacturing, TPM , FMEA (Failure Mode Analysis) and Statistical Process Control.
• Results and proactive solution driven with ability to think critically to overcome hurdles to complete tasks.
• Global experience in plastic molding machine, molds
• Basic computer skills. Microsoft Office and AutoCAD is a must. Other engineering design softwares, like UG, pro-E will be advantageous.