Process Engineer

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

. 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