Job Responsibilities: 1、 Strategic Planning and Factory Establishment : Develop and drive the overall strategic plan for factory operations from scratch, including the establishment and improvement of key functions such as production, quality, logistics planning, and engineering. Align factory capabilities with product demands in line with the group’s strategic direction, laying the foundation for long-term growth. 2、 System and Process Development : Establish and optimize quality management systems (e.g., ISO 13485) and core operational processes to ensure standardized management and compliance with industry regulations. Formulate operational processes for key departments such as production, quality, and logistics planning to prepare for future mass production. 3、 New Product Introduction (NPI) Support : Lead factory-related activities during the NPI process, including manufacturability evaluation, process development, validation, and implementation of pilot production plans. Collaborate with the R&D team to ensure comprehensive production support for technology integration and new product validation. 4、 Equipment and Production Setup : Oversee the selection, installation, validation, and commissioning of production equipment to ensure that equipment and processes meet production needs and quality standards during the initial phase. Optimize production line layouts to enhance flexibility and efficiency for both pilot and future mass production stages. 5、 Logistics and Production Planning Management : Plan and oversee the formulation and execution of production schedules to ensure resource allocation and delivery efficiency during the pilot production phase. Optimize internal logistics and warehousing processes to promote operational efficiency and cost control. 6、 Quality and Risk Management : Lead the resolution and improvement of factory quality issues, promoting synergy between production and quality to meet customer and industry standards. Develop quality management systems and processes, establish risk management mechanisms, and enhance reliability and stability across all aspects of operations. 7、 Team Building and Cultural Development : Build and manage teams for production, engineering, quality, and logistics planning, fostering capability development and talent pipelines for key positions. Cultivate a quality-focused mindset and strong execution within the team, creating a positive and efficient work culture to energize the startup team.Job Requirements: 1、Bachelor’s degree or above, preferably in engineering, science, or management; MBA is a plus. 2、Over 10 years of experience in manufacturing operations, including at least 3 years in mid-to-senior management roles. 3、At least 2 years of experience in the medical device industry; experience in multinational companies or overseas assignments is preferred. 4、Familiarity with medical device regulations and system requirements (e.g., ISO 13485, FDA, MDR), with proven success in establishing compliant quality systems. 5、Comprehensive knowledge of factory operations, production equipment commissioning, and the full NPI process. Experience in building factory operations and systems from scratch is a plus. 6、Proficiency in production planning, logistics management, and quality control processes, with the ability to optimize factory operations. 7、Fluency in English as a working language. 8、Strong execution capability, stress tolerance, and project management skills to handle the complex tasks of a startup factory. Fair, upright, resilient, and possessing excellent leadership and cross-functional collaboration skills to drive synergy across business units. Quick learner with the ability to acquire new knowledge and skills, coupled with strong self-motivation. Ability to quickly adapt to diverse cultural environments.
Job Title
Director of Production Operations