Process Engineer (Mold Tester)

Requirements

• Diploma/Degree in Mechanical Engineering/relevant field.
• Must have experience in Validation Protocol _ IQ, OQ, PQ.
• Must have experience in Perform SPD (Scientific Process Development) study.
• At least 3-5 years relevant working experience with knowledge in injection moulding field.
• 3 years hands-on working experience and process DOE will be a plus.
• Experience in Medical Device Manufacturing industry
• Experience in Minitab software will be a plus.
• ISO9001 and ISO13485 awareness certification will be a plus.
• Good communication skills
• Able to carry out technical analysis independently
• Lead a team of technicians and provide training where required
• Able to liaison with customer, interact with relevant persons in technical discussion

Additional Information

Job Description: - Provide engineering support to manufacturing operations including molding, packaging and shipment of finished products. - Support the achievement of manufacturing objectives related to safety, quality, delivery and cost. - Provide technical support and troubleshooting for daily manufacturing operations to ensure smooth production flow. - Monitor manufacturing performance and variances to identify root causes, problem solving actions and improvement opportunities. - Deliver timely resolution of product, process and equipment issues through effective short term containment and long term corrective actions. - Assist in the development, testing and optimization of manufacturing processes for both new and existing products to improve efficiency, reduce in variability and increase in yield. - Plan, coordinate and execute process validation activities including IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) for new and revised products and processes. - Conduct process characterization studies, experiments and technical evaluations to ensure process robustness. - Prepare, review and update Standard Operation Procedures (SOPs), work instructions, validation protocols and other required documentation. - Provide technical consultation and guidance to cross functional teams on product and process related matters. - Ensure compliance with quality management systems such as ISO 9001, ISO 13485 and ISO 14001. - Identify and implement engineering improvements related to process, tooling, machinery and automation systems to enhance performance. - Drive continuous improvement initiatives within the assigned Manufacturing Cell to improve efficiency, productivity and cost effectiveness. - Lead validation studies, perform process risk assessments (pFMEA), troubleshoot process issues, and develop robust manufacturing systems. - Collaborate with Engineering, QA, Production and Maintenance Teams to ensure manufacturing stability and continuous improvement.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at FU YU CORPORATION LIMITED? Share your experience