A global leader in stent and balloon technologies, we push the boundaries of vascular innovation to restore blood flow and improve patient outcomes. With cutting-edge healing-focused technology, our solutions set new standards in precision, performance, and safety. Committed to transforming lives, we're redefining vascular therapy-one breakthrough at a time.
R&D Responsibilities
- Contribute to process design, verification, and validation for related products.
- Develop operational instructions, technical drawings, and product quality requirements to ensure compliance and efficiency.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment.
- Troubleshoot equipment and tooling issues, conducting basic maintenance as required.
- Manage the transfer of technical documentation, including Device Master Records (DMR) and Design History Files (DHF).
Project Responsibilities
- Act as the primary point of contact for managing product production knowledge transfer between facilities.
- Work closely with cross-functional teams to drive projects and ensure timely execution.
- Lead project planning, progress monitoring, and risk management to enable seamless transitions.
- Oversee local production line setup, ensuring alignment with quality and efficiency standards.
- Ensure capability readiness and effective 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, preferably with balloon products.
- Strong project management expertise; PMP certification is preferred.
- Proven experience in product manufacturing transfers.
- Proficient in Microsoft Office and CAD software (SolidWorks, Creo, or similar).
- Familiarity with FDA and CE regulatory requirements.
- Fluent in German and Mandarin (spoken and written); English proficiency is a plus.
