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Polyplas in Malaysia seeks a seasoned project leader to drive engineering and process development for medical devices and semiconductor projects. You will coordinate cross-functional teams, manage timelines, and ensure quality and cost targets before mass production.
You will liaise with customers on new product introductions, design for manufacturing, and process validation, while maintaining rigorous documentation and continuous improvement.
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Lead, manage and coordinate project engineers and process development activities to ensure projects are completed according to customer requirements, quality standards, cost targets and timelines.
Liaise closely with customers on new product introduction, technical requirements, product development, manufacturing processes, process design and other activities prior to mass production.
Plan, organize and manage project activities, including establishing project schedules, monitoring progress, identifying potential risks, resolving issues and initiating appropriate corrective and preventive actions.
Coordinate and communicate effectively with relevant departments and sections on project, engineering, process and quality-related matters.
Develop and implement Design for Manufacturing (DFM) and Design for Assembly (DFA) solutions in accordance with product requirements and manufacturing capabilities.
Conduct testing, evaluation, troubleshooting and root cause analysis on mechanical designs, processes and product-related issues, and implement necessary modifications and improvements.
Ensure approval samples are prepared, evaluated and submitted to customers on time.
Monitor and coordinate sample submissions, mould trials, testing, repair, modification and improvement activities to meet project schedules and customer requirements.
Ensure manufacturing processes and process parameters are properly developed, validated and optimized before project completion and handover to the Production Department.
Ensure all relevant new project information, specifications, requirements and changes are communicated promptly and accurately to the relevant departments.
Ensure all monitoring and measuring devices under the department's responsibility are properly identified, controlled, calibrated and maintained in accordance with applicable requirements.
Lead problem-solving and continuous improvement activities relating to product design, manufacturing processes, tooling, quality and productivity.
Ensure all project documentation, technical records, process parameters, testing results and relevant reports are properly maintained and controlled.
Work closely with cross-functional teams to ensure a smooth and effective transition from project development to mass production.
Ensure compliance with the Company's quality management system, customer-specific requirements, applicable procedures and relevant standards, including ISO 9001, ISO 14001, ISO 13485, IATF 16949 and ISO 45001 requirements, where applicable.
Demonstrate creativity, innovation and a proactive, solution-oriented approach in solving technical and project-related challenges.
Perform any other duties and responsibilities as assigned by Management from time to time.
Carry out any tasks that assigned by superior from time to time.
Requirements:-
Candidate must possess at least Diploma/Advanced/Higher/Graduate Diploma, Bachelor's Degree/Post Graduate Diploma/Professional Degree in Engineering (Mechanical/Polymer) or equivalent.
At least 5 years of working experience in Engineering department for project management.
Strong project management and leadership skills.
Strong experience in managing projects and engineering activities within the medical device sector and semiconductor industries.
Good knowledge of manufacturing processes, product development and process optimization.
Strong problem-solving and root cause analysis skills.
Knowledge of DFM, DFA, process validation and continuous improvement.
Good communication and coordination skills with customers, suppliers and internal departments.
Ability to lead cross-functional teams and manage multiple projects simultaneously.
Creative, innovative and proactive in identifying improvement opportunities.
Good understanding of quality management systems and customer requirements.