Job Description Responsibilities: Responsibilities: · Coordinate and execute the molding efforts on new program launches · Conduct tooling Contract review, mold design review, mold trial review, project review meetings · Develop and install new injection molding equipment and document all implementation processes for molded products. · Provide documented procedures on buyoff on new/transfer molds prior to mass production release · Analyze and monitor manufacturing processes and data, suggest improvements, and maintain optimization of equipment. · Review, evaluate, and manage First Article Inspection Reports (FAIR). · Coordinate injection molding process validation activities (IQ, OQ, PQ) for new components. · Complete PQ reports transferring products into ongoing production. · Assist with developing and implementing Quality Procedures, Standard Operating Procedures and other manufacturing-related documentation. · Prepare requests for project funding and monitor spending against budget through the completion of the project. · Support investigation of customer complaints and initiate action to prevent the recurrence of non-conformities related to the product, processes, or the quality system. · Manage cost requests, establish manufacturing costs and equipment, and maintain knowledge of safety regulations for various processes. · Provide support to develop plastic tools for injection molding equipment and root cause analysis for injection molding processes. · Administer projects and recommend improvements to facilitate first-time quality. · Perform regular investigations and ensure optimizations for projects. · Coordinate molding trials for new programs, providing feedback for corrective actions to tooling engineering, molding and material suppliers. Requirements Requirements: Bachelor/Master Degree in Plastics, Tooling, or Mechanical Engineering (or equivalent scientific qualification). · 5+ years of relevant working experience in injection molding and plastic engineering is required, preferably in medical device molding. · Experience in Design of Experiments (DoE), injection molding process validation (IQ, OQ, PQ), and scientific molding procedures, preferably of medical equipment/ devices. · Experience in 3D CAD applications and interpretation of plastic injection molding simulation software tools (e. g. Moldflow or Moldex3D) is desired. · Experience in project work, problem-solving techniques, analytical and structured approaches, and teamwork. · Understanding and familiarity with ISO 13485, medical product quality standards and health & safety regulations · Time management skills and the ability to delegate. · A team player with ability to work under minimum supervision Benefits Benefit Update: 13 months bonus Performance bonus (subject to the yearly performance of the company and the individual employee) Medical Claim (RM60/claim; max 500/yr) Dental/Optical (RM300/yr) Insurance coverage (Hospitalization, Life, Personal Accident) Transport allowance Meal allowance Attendance Allowance Yearly 15 days public holidays Yearly min. 15 days annual leave
