【Job Responsibilitie】
1. Plan, Coordinate, and Monitor Feasibility R&D Projects:
- Support the CTO in planning and coordinating cross-disciplinary R&D feasibility studies and projects.
- Define technical requirements, deliverables, and timelines in collaboration with stakeholders and experts.
- Communicate effectively with R&D, Operations, Marketing, Regulatory, Clinical teams, suppliers, and external partners.
- Manage NDAs and contracts with third-party collaborators when needed.
- Provide regular progress reports, meeting minutes, and summaries.
2. Initiate Formal Project Kick-offs
- Launch formal projects (product life cycle management) upon successful completion of feasibility phases. Create final feasibility study report, assist with responsibility transfer to cite managers.
- Coordinate and transfer information to ensure smooth and successful implementation at project sites.
- Facilitate communication among stakeholders and provide initial support for new projects.
3. Support Process Flow with Technical Information Collection
- Gather and analyze technical data and product specifics from marketing materials, patent applications, scientific articles, and key opinion leaders.
- Develop rationales and justifications for project decisions.
- Apply for government-sponsored programs and navigate policies to support innovative developments.
4. Provide Technical Assistance to the CTO
- Compose concise technical summaries and reports.
- Review competitor technologies, products, and analyze key players’ patent portfolios. Closely communicate with Marketing colleagues.
- Offer comprehensive daily technical support to aid strategic decision-making.
【Qualification for Employment】
1.Educational degree/major/age
- Degree: Minimum Master’s Degree (MSc) in a technical discipline such as Mechanical, Electrical, Optical, Chemical Engineering, or related fields.
- Age: 25–45 years.
2.Relevant work experience
- Industries: Experience in the medical device, pharmaceutical, or medical equipment sectors.
- Project skills: Experience with project coordination and monitoring.
- Preferred: Background in the ophthalmic industry is highly advantageous!
3.Employability skills (relevant vocational competencies matched with job requirements, ranked by importance)
- Industry Experience: Over 5 years in the medical device or pharmaceutical industries.
- Adaptability & Creativity: Demonstrated ability to learn quickly and innovate. Initiative and open-minded!
- Communication: Skilled in building and maintaining effective communication channels among diverse stakeholder groups.
- Project Management: Proficient in project coordination and management, with knowledge of relevant tools and software.
- Technical Proficiency: Experience working with technical and scientific information, including technical study reports, patents and research articles. Ability to summarize information and identify key details.
- Regulatory and QA Knowledge: Understanding the principles of ISO 13485, or 21 CFR, and other Quality Management System (QMS) requirements specific for medical device industry, particularly Design Control and Change Control procedures.
- Additional Skills: Competence in data analysis, statistics, programming, optics, materials, or related areas is a plus.
4.Additional requirements
- Perfect English, written and spoken, ability to comunicate clearly on technical subjects and use commonly accepted terminology.
- Positive attitude to work and colleagues.
【岗位职责】
1. 规划、协调和管控可行性研发项目：
- 在CTO的协助下规划和协调跨学科的研发可行性研究和项目。
- 与利益相关者和专家合作定义技术要求、交付成果和时间表。
- 与研发、运营、市场、监管、临床团队、供应商和外部合作伙伴有效沟通。
- 在需要时管理与第三方合作者的保密协议和合同。
- 提供定期进度报告、会议记录和摘要。
2. 启动正式项目启动
- 在可行性阶段成功完成后，启动正式项目（产品生命周期管理）。创建最终的可行性研究报告，协助责任转移给项目经理。
- 协调和转移信息以确保项目现场的顺利和成功实施。
- 促进利益相关者之间的沟通，并为新项目提供初步支持。
3. 通过技术信息收集支持流程
- 收集和分析来自市场资料、专利申请、科学文章和关键意见领袖的技术数据和产品细节。
- 为项目决策制定理由和依据。
- 申请政府资助项目并导航政策以支持创新发展。
4. 为CTO提供技术支持
- 撰写简洁的技术摘要和报告。
- 审查竞争对手的技术、产品，并分析关键玩家的专利组合。与市场同事密切沟通。
- 提供全面的日常技术支持以协助战略决策。
【任职资格】
1. 教育程度/专业/年龄
- 学位：机械、电气、光学、化学工程或相关专业的硕士及以上学位。
- 年龄：25至45岁。
2. 相关工作经验
- 在医疗器械、制药或医疗设备领域有经验。
- 有项目协调和管控经验。
- 具备眼科行业背景优先考虑
3. 技能（与工作要求相匹配的相关职业技能，按重要性排序）
- 行业经验：在医疗器械或制药行业超过5年的工作经验。
- 适应性与创造力：展现出快速学习和创新的能力。积极主动和思维开放！
- 沟通：擅长建立和维护有效的沟通渠道。
- 项目管理：熟练进行项目协调和管理，了解相关工具和软件。
- 技术熟练度：有处理技术性和科学性信息的经验，包括技术研究报告、专利和研究文章。能够总结信息并识别关键细节。
- 法规和质量保证知识：理解ISO13485或21CFR以及其他针对医疗器械行业的质量管理系统（QMS）要求，特别是设计控制和变更控制程序。
- 其他技能：数据分析、统计、编程、光学、材料或相关领域的技能是加分项。
4. 其他要求
- 英语能熟练运用于书面或口语，并且能够在专业技术上清晰沟通并使用术语。
- 协同意识佳、工作态度积极。