Monitoring and evaluate plastic injection mold performance at vendor site, and lead the project to develop new mould for capacity expansion and replacement from design until qualified for mass production.
Work as project leader, coordinate between R&D and mold maker, develop new mould from prototype stage until mass production stage.
Work with in-house manufacturing and quality team collaboratively to qualify new tooling.
Compile tooling and moulding related documentation in accordance to the regulatory requirement and keep the high-quality standard of moulded 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 moulding, or diploma in engineering with more than 5 years’ experience in project management industry.
Min 3 years of hands-on experience in mould design/ design for manufacturing for product and tooling design optimization.
Min 3 years’ technical experience in medical device/ pharmaceutical industry, and familiar with ISO13485 requirements for IQ/OQ/PQ validation.
Track record of tooling project management, dealing with mold makers and moulding suppliers in the region.