此岗位必需要有有源、三类医疗器械相关经验,请谨慎投递,谢谢~
一、岗位职责:
1.负责公司产品设计和开发、产品设计转换和量产技术支持工作;Responsible for the company's product design and development, product design conversion and mass production technical support;
2.不断优化、改进产品设计; Continuously optimize and improve product design;
3.对产品进行持续的质量策划,确保产品设计和开发符合相关法律、法规、标准的要求; Carry out continuous quality planning for products to ensure that product design and development meet the requirements of relevant laws, regulations and standards;
4.负责组织开展风险管理活动;Responsible for organizing risk management activities;
5.制定技术文件,协助人力资源部组织实施技术人员的培训考核;Formulate technical documents and assist the human Resources Department to organize and implement the training and assessment of technical personnel;
6.组织进行特殊过程的确认方案,针对关键工序确定管控要求; Organize confirmation plans for special processes and determine control requirements for key processes;
7.识别并评估公司基础设施和工作环境,确定控制要求; Identify and evaluate company infrastructure and work environment to determine control requirements;
8.完成上级主管或公司交付的其他相关工作;Complete other related work assigned by superiors or the company;
二、任职要求:
本科及以上学历,机械设计、模具制造或机电一体化等相关专业;有相关产品研发经验的可降低至大专学历。
Bachelor degree or above, major in mechanical design, mold manufacturing or mechatronics; Experience in product development can be reduced to a college degree.
熟悉医疗器械设计开发流程;
Familiar with medical device design and development process;
医疗器械有源类产品相关工作经验5年以上优先;
More than 5 years working experience in medical device active products is preferred;
需熟练使用Office等办公软件、熟练使用二维及三维作图软件等;
Proficient in Office software, 2D and 3D mapping software, etc;
有相关产品研发经验可优先考虑。
Relevant product development experience is preferred.
了解有源医疗器械相关安规EMC项目测试、标准,如GB 9706.1及质量管理体系。
Understand active medical devices related safety and EMC project testing and standards, such as GB 9706.1 and quality management system.
三、公司基本情况:
单双休(早8点,晚4点半),法定节假日全放,能接受加班;
入职就缴纳五险一金,有餐补,三节福利,在职体检,定期聚餐等,工作氛围好,公司环境好,领导和蔼可亲,公司发展稳定。