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Sunningdale Tech Penang Sdn Bhd is seeking a seasoned engineer to lead Process and Project Engineering functions, driving NPI, product transfers, and validation to meet quality and regulatory standards. The role demands strong leadership, project management, and cross-functional collaboration in a high-volume manufacturing environment.
Ideal candidates hold a Bachelor's in Engineering with 8–10 years in plastic injection molding, possess expertise in IQ/OQ/PQ,ISO 13485/9001, and SAP/MS Office.
To lead Process Engineering and Project Engineering functions, managing new product introduction (NPI), process development, validation, and project execution to ensure quality, delivery, regulatory compliance, and customer satisfaction.
Job Responsibilities
Lead and manage project and process engineering activities, ensuring successful execution of NPI, product transfer, and engineering projects within approved timelines, budgets, and quality requirements.
Oversee process development, optimization, and validation for injection molding and secondary processes to improve productivity, quality, capacity utilization, and manufacturing efficiency.
Lead cross-functional teams and coordinate with customers, suppliers, and internal stakeholders to ensure project objectives, deliverables, and customer requirements are achieved.
Drive validation and qualification activities, including IQ, OQ, PQ, process validation, and documentation in compliance with ISO 13485, ISO 9001, and customer requirements.
Ensure machine, tooling, auxiliary equipment, and production capacity are sufficient to support business growth, forecast demand, and operational readiness.
Monitor project risks, timelines, resources, engineering changes, and project documentation while implementing effective corrective and preventive actions.
Drive continuous improvement initiatives, technical problem-solving, cost reduction programs, and manufacturing excellence to enhance operational performance and customer satisfaction.
Qualification & Requirement
Bachelor's Degree in Engineering or related discipline with minimum 8-10 years of experience in plastic injection molding, manufacturing engineering, project management, or NPI environments.
Strong knowledge of injection molding processes, tooling, scientific molding, validation (IQ/OQ/PQ), drawing interpretation, and manufacturing process optimization.
Well-versed in ISO 13485, ISO 9001, ISO 14001, GMP, and medical device manufacturing requirements.
Proven leadership, project management, communication, analytical, and problem-solving skills with proficiency in SAP and Microsoft Office.
Machinery & Automation 101-1,000 employees
Product & Services
Our main products are injection molding precision plastic parts and complete assembly of ink cartridges by applying full auto machines. We also provide spray printing work for our customers.
Product & Services
Our main products are injection molding precision plastic parts and complete assembly of ink cartridges by applying full auto machines. We also provide spray printing work for our customers.