Process Engineer (Process Engineering Dept)

Reporting to Production Manager / Operation Manager Job Purpose: The Process Engineer is responsible for ensuring that moulding process and improvement meet Fu Yu Corporation’s quality standards and regulatory requirements. This role drives moulding quality monitoring, process monitoring, and standardization to minimize risks and non-conforming products. Job Responsibilities: · 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 variability, and increase 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 Operating 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. Job Requirements: · Diploma/Degree in Mechanical Engineering/relevant field. · At least 3-5 years relevant working experience with knowledge in injection moulding field · 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 Salary: $3,000 – $4,300 Working Hours: Monday -Friday, 8.15am-5.30pm Work Location: 9 Tuas Drive 1, Singapore 638676