Job Description Position Summary: - We are hiring a highly dedicated NPI Engineering Manager who will oversee and manage all Project Management and NPI activities on in the company. Job Responsibilities: - Taking the necessary action to ensure that the standards related to ISO 13485, GMP, product ISO standards and other regulatory requirements are achieved at all times. Initiate/implement projects and improvement /enhancement programs in relation to: Technical Support to manufacturing and technical sales New material investigation & evaluation New customer technical support Manufacturing process development Validation and re-validation activities Process verification activities Responsible for: Initiate Validation Master Plan for new projects Develop manufacturing process for new projects Provide technical support to other departments in product quality, manufacturing concerns and customer complaints Generate project proposals in conjunction with customers and the marketing department. Ensure that the manufacturing process of all products is developed in a controlled manner and adhere to existing regulatory requirements. Produce regular progress reports on assigned projects. Control the transfer of the manufacturing process of new products to production. Develop new process and modify existing production process as identified by the Top Management. Evaluate competitor products when applicable to new development and keep up to date with current changes in technology. Ensures that trials/validation programs that involve engineering are completed on a cost effective and timely basis. Review and evaluate change requests from supplier and customer. Authorized to stop production if equipment and/or process used in production not in state of validated Authorized to approve new process parameter for production operation Authorized to approve new tool/mold/die/jig to be utilized in the production Authorized to approve new components/materials to be used in the production Carry out/manage any other projects or tasks as requested by the Managing Director and/or Technical/NPI Director from time to time. Requirements Candidate must possess at least a college Degree in Engineering / Science & Technology or equivalent with a thorough working knowledge of High Tech / Engineering principles essential. At least three (3) years' experience in project management / research & development preferably with experience in moulding, assembly and automation process. Preferably with working experience in a manufacturing environment that is ISO 13485 certified. Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP. Initiative, creativity, resourcefulness and ability to work independently are essential. Good written and spoken English and Bahasa Melayu. Computer literate.
