Process Engineering Supervisor

About the Company

The company is a well-established manufacturer of Class-III medical consumables with over 30 years of experience. It is certified with ISO 13485 QMS, and its products hold China NMPA registration, with some also certified by 3C (China), CE (EU), and FDA (US). The product range includes blood purification consumables, nutrition devices, I.V. catheters and infusion devices, physical therapy and rehabilitation devices, medical polymers, hygiene materials, and ward care apparatuses. With advanced equipment, strong environmental protection measures, and a robust quality control system covering all stages from raw material procurement to product delivery, the company ensures high product quality. Its products are sold across major Chinese cities and internationally in Asia, Europe, America, and South America, establishing a strong brand presence for TYH in both domestic and global markets. Location: Tianyi Medical (Thailand) at AMATA City industry, Rayong, Thailand.

About the Role

We are looking for a detail-oriented and proactive Product Process Engineer to join our Technical Department. You will play a critical role in bridging the gap between R&D and commercial production, ensuring that our medical devices are manufactured with the highest efficiency, quality, and compliance with international standards.

Responsibilities

• Production Transition: Convert R&D data (BOMs, drawings, and technical standards) into practical Work Instructions (WI) for mass production.
• Process Design: Design and optimize process routes and production layouts for new and existing products.
• Continuous Improvement: Analyze production data to improve yields, reduce waste, and optimize manufacturing costs.
• Technical Maintenance: Manage design changes, update technical documentation, and ensure all process parameters are accurately maintained.
• Validation Support: Assist the validation team in IQ/OQ/PQ activities to ensure equipment and processes meet regulatory requirements.
• Troubleshooting: Provide technical support to the production floor to resolve process-related issues promptly.

Qualifications

• Education: Bachelor's degree or higher in Engineering (Industrial, Mechanical, Materials, or related fields).
• Experience: Minimum 3 years of experience in process engineering or R&D.
• Industry Expertise: Direct experience in Class III Medical Device manufacturing is highly preferred.
• Technical Skills: Proficiency in manufacturing processes such as Turning, Extrusion, Injection Molding, and Welding.
• Strong understanding of Medical Polymers and their processing characteristics.
• Knowledge of ISO 13485 and relevant medical device regulatory standards.
• Proficient in AutoCAD, SolidWorks, or similar engineering software.
• Soft Skills: Strong analytical thinking, problem-solving skills, and the ability to work effectively in a cross-functional team.