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Jora Malaysia seeks an experienced Process Development Engineer to advance injection molding programs for medical devices in Penang. You will develop processes for existing and new molds, train technicians, and drive trials for optimization and cost savings.
Collaboration with R&D and project teams will be essential as you implement ISO 13485 compliant practices. Applicants should have an engineering degree and hands-on mold experience in medical molding, with strong analytical and
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Perform Process development on existing and new molds in a systematic manner, where the impact from mold, material, machine, and equipment is well balanced against specification, measurement, and performance.
Train and educate technicians so that a similar understanding and knowledge is shared and adapted in daily operation across all molding processes.
Mold and material trial in relation to optimizing projects, cost-saving projects, R&D projects, etc.
Troubleshot issues and new projects to fit the best possible solution, considering the total setup.
Perform analysis on test and data using statistical tools to gain precise information and get to the correct conclusion.
Document and properly file all investigations and results for easy access at a later stage.
Capable of reading and understanding specifications and requirements in a broader perspective and translating this into the daily work.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Lead and execute a comprehensive Validation Project (FAT, SAT, IQ, OQ, PQ).
Drive the successful completion of assigned MDR and ISO projects (e.g., process studies, verification, PS, MAC, and CP monitoring).
A relevant engineering or technical degree is preferred.
Proven hands-on experience in injection molding, specifically within the medical device industry.
Strong motivation to continuously learn and grow in medical molding technologies.
Demonstrated ability to work effectively with R&D and project teams on design and material modifications.
Capable of leading technicians with strong analytical and troubleshooting skills.
Familiarity with ISO 13485 standards and requirements for medical device manufacturing.
Scientific Injection Molding Process Development, Tooling design using SolidWorks, Part simulation using Moldflow, Moldex3D, or equivalent software, and Statistical analysis using Minitab.