职位描述和范围: - 医疗器械文献研究,包括专利、监管、创新技术和应用理念等; - 协助团队开发战略产品。 - 与研发团队进行车间操作,制作原型并进行实验; - 与团队一起在原型中执行验证和测试协议; - 排除故障并进行根本原因分析和解决问题的过程。 - 协助管理相关技术文件和分析工程设计; - 与供应商、合作伙伴和OEM进行沟通; - 维护、更新和跟进ISO13485、9001管理体系 - 协助部门主管安排会议日程和项目计划监控团队流程阶段。 - 临时任务支持。 要求: - 生物医学工程/工程管理/机电一体化硕士或同等学历; (本科生至少两年资格后工作经验和优秀的应届毕业生亦考虑); - 了解定量和定性数据集合以进行基础分析。 (熟练使用EXCEL vlookup函数) - 文献检索技巧和综述总结 - 需要车间或实验室的实践和动手技能; - 项目规划技能(会议安排、项目监控、资源计划) - 良好的团队合作精神,能够独立工作并承受压力。 - 学习速度快,注重细节,对各种尖端技术充满热情; - 良好的英语、普通话和粤语口语和书写能力。 - 了解临床知识和项目或工程方面的专业合格证书将是首先考虑的因素。 - 需要与部门负责人一起在中国出差 3 ~ 4 天。 (中国办事处、工厂和合作伙伴)不论是国内或中国香港应征者,必须要往返异地上班。 - 不适合在工作日学习夜校课程的申请者。 Research Engineer with Assistant of dept. head request below Job Description & Scope: - Literature research for medical devices, including Patents, Regulatory, Innovation technologies and Application Concepts., etc.; - Assist team with developing strategic products. - To perform workshop operations to make prototypes and experiments with R&D teams; - To carry out verification and testing protocols in the prototypes with a team; - To troubleshoot and conduct root causes analysis and problem-solving process. - To assist in managing related technical documents and analyzing engineering design; - To communicate with the vendors, partners and OEM; - To maintain, update and follow up the management system of ISO13485, 9001 - To assist the department head in arranging meeting schedules and project plan monitoring team process stages. - Ad-hoc mission support.
Requirements: - Master in Bio-medical Engineering / Engineering Management / Mechatronic or equivalent; (Bachelor at least two years post-qualification job experience and outstanding first graduate will be considered); - Understand Quantitative and Qualitative data collective to foundation analysis. (Skillful use of EXCEL vlookup function) - Literature searching skills and review summary - Practical and hands-on skills in workshops or laboratory are required; - Skill in project planning (meeting arranging, project monitoring, resource plan) - Good team player with the ability to work independently and under pressure. - Fast learner, attention to detail, passionate about a wide range of cutting-edge technologies; - Good command of spoken and written English, Mandarin and Cantonese. - Knowing clinical knowledge and a professionally qualified certificate in project or engineering will first be a consideration. - Needs to travel 3 ~ 4 days in PRC with dept head. (PRC office, Factories and partners) - Not suitable for applicants study