Responsible for monitoring and evaluating plastic injection mold performance at vendor site, and lead the project to develop new tooling for capacity expansion and replacement/renewal.
To trouble shoot IOL and injector defects potentially related with injection molding production which occurs in the vendors’ manufacturing sites, drive solutions with data analysis and fact based approach.
New Product Development Support
Work as project leader, coordinate between R&D and tool maker, develop new tooling from prototype stage until mass production stage.
Work with in-house manufacturing and quality team collaboratively to qualify new tooling. The tooling are for injector parts, IOL optical PP mold, and process aids for material production.
Compile tooling and molding related documentation in accordance to the regulatory requirement and keep the high quality standard of molded components.
Initiate the 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.
3 years of plastic injection molding / QA experience in medical device industry
Degree or diploma in mechanical or chemical engineering
Logical thinking and able to summarize engineering testing and complete reports in English.
Foundation molding process knowledge is required, and Scientific Molding practitioner is and lean six sigma green belt is a plus
Track record of tooling project management experience, dealing with tool makers and molding suppliers in the region.
Hands on experience in tooling design and Design For Manufacturing (DFM) for product and tooling design.
Technical experience in injection molding in medical device, and familiar with ISO13485 requirement for IQ/OQ/PQ validation.
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Tan Wai Peng | Registration No: R1104671