Process Engineer (Mold Tester)

Job Description:

• Provide engineering support to manufacturing operations including injection moulding, plastic parts assembly, 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 or equivalent.

· 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

Job Types: Full-time, Permanent

Pay: $3,000.00 - $3,800.00 per month

Work Location: In person