R&D Responsibilities Participate in process design and verification/validation for related products. Prepare operational instructions, technical drawings, and product quality requirements. Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment. Troubleshoot equipment and tooling issues, along with performing basic maintenance as needed. Transfer technical documentation, including Device Master Records (DMR) and Design History Files (DHF). Project Responsibilities Serve as the primary contact and manage the entire process of transferring product production knowledge between facilities. Collaborate with cross-functional teams to drive projects and ensure adherence to timelines. Oversee project planning and progress control to facilitate smooth and successful transitions. Supervise the setup of local production lines, ensuring compliance with quality and efficiency standards. Ensure readiness of capabilities and proper transfer of project-related knowledge and technology. Qualifications Bachelor’s degree or higher in Engineering, Materials Science, Mechanical Engineering, or a related field. Minimum of 5 years of experience in the Class III Medical Device industry, with a preference for experience in balloon products. Strong project management experience, with Project Management Professional (PMP) certification preferred. Demonstrated experience in product manufacturing transfers. Proficient in Microsoft Office and CAD software such as SolidWorks or Creo. Familiarity with FDA and CE regulatory requirements. Proficiency in German and Mandarin, both spoken and written, is essential; English proficiency is a plus.