Job Description:
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.