CAIR, HKISI, CAS

<p><strong>Duties include:</strong></p><p>1. Project full life cycle management: Responsible for the full life cycle management of medical device new product development projects from project initiation to market launch, formulate detailed project plans, control project progress, quality, cost and resource allocation, and ensure that projects are completed and delivered on time and of high quality. For example, in the product development stage, reasonable scheduling of R&D personnel's work tasks and time nodes is arranged to ensure smooth progress of R&D work. </p><p>2. Team coordination and communication: Form and manage a cross-functional project team, including R&D, production, quality, marketing, etc. Promote effective collaboration and communication among team members, timely resolve problems and conflicts in team collaboration, and ensure project goals are consistent. Regularly organize project team meetings to share project progress, coordinate departmental work.</p><p>3. Regulations and standards compliance: In-depth understanding of the medical device industry related regulations, standards and policies, such as the Medical Device Supervision and Management Regulations, etc., ensure that the project development process strictly complies with the regulations, organize and complete product registration, clinical trials and other related work, prepare and submit the required application documents and other information.</p><p>4. Risk Management: Identify, assess and respond to various risks in the project, develop risk response strategies and contingency plans, and real-time monitor potential risks that may affect project progress, quality and cost, take timely measures to reduce risk impacts, and ensure the project is smoothly carried out. For example, for raw material supply risk, identify backup suppliers in advance. </p><p>5. Market and customer demand research: Monitor medical device market dynamics and competitive situations, collect market information and customer needs, provide market orientation for product research and development, promote continuous optimization and innovation of products, and improve product market competitiveness. Regularly communicate with the marketing department to understand changes in market demand. </p><p>6. Project document management: Establish and maintain a complete project document system, including project plans, meeting minutes, technical documentation, test reports, etc., to ensure the traceability of project processes and outcomes, and provide experience references for future projects.</p><p></p><p><strong>Job Requirements</strong></p><p>1. Educational background: Bachelor's degree or above, clinical medicine, biomedical engineering, mechanical engineering, electronic engineering, etc. Medical device related majors are preferred.</p><p>2. Work experience: More than 5 years of project management experience, of which at least 2 years are medical device industry project management experience, those with three-class powered medical device project management experience are preferred. Have complete medical device product R&D to market project management experience, familiar with the medical device design and development process.</p><p>3. Professional skills: Familiar with the regulations, standards and norms of the medical device industry, such as ISO13485 medical device quality management system; have project management professional knowledge, master project management tools and methods, such as Gantt chart, critical path method, etc.; have good technical understanding ability, be able to communicate effectively with technical teams, and solve technical problems. </p><p></p><p>5. Certificate qualifications: Holders of the PMP (Project Management Professional) certificate are preferred.</p>