Process Engineer (Mold Tester)

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.

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