Project Manager

Project Manager
产品开发项目经理
Job Description
岗位职责：
1. Collect and consolidate product related technology and market information. Architect technology program according to product design
收集、整理产品相关技术、市场信息，根据产品设计需求制定技术方案；
2. Make plans for product development, coordinate resources and oversee product development process
制定产品开发计划，协调资源，全程跟踪产品开发流程；
3. Calculate and determine project budget and project management cost, resolve any technical issues during project progression.
制定项目预算，管理项目成本，主导解决项目进程中的技术问题；
4. Direct technical evaluation on product project approval, design change or process change
主持产品开发立项，设计变更或工艺变更的技术评审；
5. Arrange document control on product development flow and history
整理产品开发的历史控制文档；
6. Provide compliant documentation to regulatory department and support registration evaluation and clinical trials.
向注册法规部提交合规文件，配合开展注册检验和临床试验；
7. Support strategic development and planning of the company, lead and build company technical team and enforces execution of company quality system
协助公司技术发展战略规划，技术团队建设，以及公司质量体系的监督执行等。

Job Qualification
任职要求：
1. Master degree or above, major in mechanic design, bioengineering, material or similar
硕士以上， 具工程教育背景（机械设计，生物医学工程，材料学或类似相关专业）；
2. Minimum 5-year experience in medical device industry, good knowledge on ISO13485 and GMP requirement
有5年以上心血管医疗器械行业的工作经历，熟悉ISO13485和GMP的要求；
3. Familiar with Class III interventional cardiology product design, development process control and associated regulations.
熟悉三类心血管介入产品的设计开发控制及相关法规要求；
4. Strong ability to learn and to be creative
学习能力强，具有创新意识；
5. Excellent skill on organization and coordination with teamwork mindset.
具有优秀的组织协调能力和团队合作精神