Company Overview
Tianyi Medical is an experienced medical device manufacturer with more than 30 years of industry experience. Tianyi Medical (Thailand) is developing its manufacturing operation in Thailand with a focus on medical devices and consumables. The company operates under international quality and regulatory requirements, including ISO 13485, and serves customers in China and international markets.
Position Overview
The Process Engineer is responsible for developing, optimizing, controlling, and improving manufacturing processes to ensure stable production, consistent product quality, productivity, and compliance with applicable medical device quality requirements. The role works closely with Production, Quality, R&D, Maintenance, Engineering, and other cross-functional teams to solve process issues and support new product and process introduction.
Key Responsibilities
- Develop, establish, and optimize manufacturing processes, process flows, work methods, and process parameters.
- Analyze production processes and identify opportunities to improve process stability, yield, productivity, cycle time, and cost.
- Provide technical support and troubleshooting for production process issues, defects, equipment-related problems, and process abnormalities.
- Conduct root cause analysis and implement corrective and preventive actions for process-related problems.
- Define, review, and optimize critical process parameters to ensure consistent product quality and process capability.
- Support process trials, pilot production, process qualification, and mass production readiness.
- Participate in New Product Introduction (NPI), process transfer, and production ramp-up activities.
- Develop and maintain process-related documentation, including Process Flow, SOP/Work Instruction, Process Specifications, Control Plans, PFMEA, and related technical documents.
- Support process validation and qualification activities, including IQ, OQ, PQ, and other applicable validation activities.
- Work closely with Quality Assurance/Quality Control to ensure process changes and improvements meet product quality and regulatory requirements.
- Support engineering change, deviation, CAPA, and change control activities related to manufacturing processes.
- Monitor process performance and manufacturing KPIs, including yield, scrap, defect rate, cycle time, downtime, and process capability.
- Lead or participate in continuous improvement projects to reduce defects, waste, cycle time, and production costs while improving process efficiency.
- Conduct and support technical investigations using appropriate problem-solving and data analysis methods.
- Provide technical training and guidance to production personnel on process requirements, parameters, and standard work.
- Work with Maintenance and Engineering teams to improve equipment performance and process reliability.
- Ensure manufacturing processes are implemented in accordance with company procedures, ISO 13485, and applicable medical device requirements.
Qualifications
- Bachelor's degree or higher in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering field.
- 3–7 years of experience in Process Engineering, Manufacturing Engineering, Production Engineering, or a related role in a manufacturing environment.
- Experience in medical device manufacturing is highly preferred.
- Experience in plastic processing, injection molding, medical consumables, or precision manufacturing is an advantage.
- Strong understanding of manufacturing processes, process parameters, troubleshooting, and root cause analysis.
- Experience with process validation, qualification, IQ/OQ/PQ, or similar engineering validation activities is preferred.
- Experience with New Product Introduction (NPI), process transfer, or production ramp-up is preferred.
- Knowledge of ISO 13485 and medical device manufacturing requirements is an advantage.
- Strong analytical, problem-solving, and project coordination skills.
- Good communication and cross-functional collaboration skills.
- Good command of English is preferred; Chinese language skills are an advantage.
- Proficient in Microsoft Office, especially Excel, for data analysis and reporting.
Technical Skills
- Process Development & Optimization
- Process Troubleshooting & Root Cause Analysis
- Process Parameters & Process Capability
- Process Validation / IQ / OQ / PQ
- New Product Introduction (NPI)
- Process Transfer & Production Ramp-up
- PFMEA / Control Plan / Process Flow
- CAPA / Change Control / Engineering Change
- Yield / Scrap / Cycle Time / Productivity Analysis
- Lean Manufacturing & Continuous Improvement
