Essential Duties and Responsibilities.
- Lead design of local Peritoneal Dialysis devices as well as integrated solutions (combination with disposables, PD solutions, Apps and other devices or SW from internal or 3rd party) for China market according to defined strategy or projects. Including but not limited to: customer needs collection and analysis, functional requirement development, concept and high-level design, feasibility study, design transfer, trouble shooting, etc.
- Support NMPA approval of local and global Peritoneal Dialysis devices, including but not limited to support/execute type testing, prepare R&D related dossier, answer technical questions, support CER and clinical trial, etc.
- Cooperate with cross functional team and global R&D to sustain current Peritoneal Dialysis devices on China market. Support to investigate and solve site issues.
- Responsible for compliance of Peritoneal Dialysis related regulations and standards. Provide technical comments to shape policies.
- Serve as main contactor between China function teams and global R&D to enhance collaboration and support to China business.
- Support global R&D to understand China requirements. Collect, translate and clarify China specific requirements as input to product core team.
- Provide technical support to China factories, Commercial, Service, RA and other function teams. Support business development in China.
Qualifications.
- Self-motivated with good communication skills. Strong written, verbal, and interpersonal skills while communicating in both English and Chinese.
- Capable of analyzing and solving complex problems individually or cooperating with team.
- Experienced in development and lifecycle management of electromechanical medical devices with strong technical background.
- Deep domain knowledge of medical devices in systems engineering and at least one of the following disciplines: electrical HW design, Usability, Reliability, SW lifecycle management or Hydrodynamics.
- Understanding and adherence to NMPA, FDA and EU MDR design control principles, requirements, regulations, standards and good practice.
- Comfortable working in a cross-culture environment, teamwork spirit and open-minded.
Education and/or Experience.
Bachelor with at least 8 years’ experience, Master or Ph. D. with at least 5 years of experience in medical devices or relevant industries.
Major in Electrical, Computer Science, Software engineering, Biomedical engineering, Physics or other relevant education background.
Experience should include at least 3 years of relevant technical management/coordination experience, e.g. Technical Project Leader, Lead System Designer, System Engineer, Lead System Integration, etc.
Pro experience to coordinate global R&D and/or local MK is preferred.
Prio experience in Dialysis is a plus.