Responsibilities:
61 Lead design of local Peritoneal Dialysis devices and digital products as well as integrated resolutions (combination with disposables, 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.
61 Support NMPA approval of local and global Peritoneal Dialysis devices and digital products, including but not limited to support/execute type testing, prepare R&D related dossier, answer technical questions, etc.
61 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.
61 Responsible for compliance of Peritoneal Dialysis related regulations and standards. Provide technical comments to shape policies.
61 Serve as main contactor between China function teams and global R&D to enhance collaboration and support to China business.
61 Support global R&D to understand China requirements. Collect, translate and clarify China specific requirements as input to product core team.
61 Provide technical support to China factories, Commercial, Service, RA and other function teams. Support business development in China.
61 Experienced in development and lifecycle management of medical software or electromechanical medical device.
61 Deep domain knowledge of medical SW/device in systems engineering and at least one of the following disciplines: SW lifecycle management, electrical/communication design, Cybersecurity, requirement/test management, R&D project management, Human factor/Usability Engineering, Reliability Engineering, Hydrodynamics.
61 Self-motivated and eager to learn and improve.
61 Strong written, verbal, and interpersonal skills while communicating in both English and Chinese.
61 Capable of analyzing and solving complex problems individually or cooperating with team.
61 Understanding and adherence to NMPA or EU MDR design control principles, requirements, regulations, standards and good practice.