Monitoring and evaluate plastic injection mold performance at vendor site, and lead the project to develop new mold for capacity expansion and replacement from design until qualified for mass production.
To troubleshoot injector defects potentially related to injection molding production occurring at vendors’ manufacturing sites, drive solutions with data analysis and fact-based approach
Work as project leader, coordinate between R&D and mold maker, develop new mold from prototype stage until mass production stage.
Work with in-house manufacturing and quality team collaboratively to qualify new tooling.
Compile tooling and molding related documentation in accordance to the regulatory requirement and keep the high-quality standard of molded components.
Initiate change control submission and review, conduct risk assessment, draft and get validation plan, validation protocol and report reviewed and approved based on the project master timeline.
Degree in mechanical or chemical engineering field related to plastic injection molding, or diploma in engineering with more than 5 years’ experience in medical device/ pharmaceutical industry
Min 3 years of hands-on experience in Design for Manufacturing (DFM) for product and tooling design optimization.
Technical experience in medical device/ pharmaceutical industry, and familiar with ISO13485 requirements for IQ/OQ/PQ validation.