岗位职责: (Senior) R&D manager will be leading R&D initiatives, responsible for overseeing the development of new products in compliance with regulatory standards and ensuring that projects align with the company’s strategic objectives. You will play a key role in ensuring that our R&D efforts translate into commercial success. (高级)研发经理将管理研发项目,负责新产品的开发符合医疗监管标准,确保新产品开发与公司的战略目标保持一致,助力业务的长期发展。 61 Develop and manage R&D team in new product development 搭建并管理研发团队开发新产品 61 Develop and implement R&D strategies that align with the business growth strategy 制定并实施符合业务增长战略的研发策略 61 Source and evaluate the capabilities and qualifications of contract developers/ manufacturers for co-development when necessary 寻找并评估合约开发商/制造商的能力与资质,以便在必要时进行共同开发 61 Design, develop new medical devices and conduct design verification and validation testing in compliance with regulatory standards 设计、开发新的医疗器械,并按照监管标准进行设计验证和有效性测试 61 Develop and maintain documentation on design control and risk management activities for projects 编制并维护与项目设计管控和风险管理活动相关的文件 61 Present key R&D updates to both China and global senior leadership team 向中国和全球高层领导团队汇报重要的研发进展 61 Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position 关注和遵守公司要求的质量、环境健康手册、管理体系和管理政策、目标和该职位的相关的法规要求 任职要求: 61 Bachelor’s or Master’s degree in a relevant field such as Engineering, Science, or Technology. 工程、科学或技术等相关领域的学士或硕士学位 61 Proven experience in R&D management, preferably within medical device sector 具有医疗器械行业研发管理经验者优先 61 Strong understanding of research methodologies and their application in product development; experience of system engineer is highly preferred 对研发方法及其在产品开发中的应用有深刻的理解;有系统工程师经验者优先考虑 61 Excellent communication skills in both Chinese and English 优秀的中、英文沟通交流能力 61 Strong problem-solving skills and the ability to think strategically. 较强的问题解决能力与战略思维