• 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述: Activities in the scope of the Manufacturing Process Engineer position include but are not limited to:制造与工艺工程师职位责任范围包括但不限于: Coordinating, Performing, test, and Writing validations protocol and report of product, processes and equipment in accordance with FDA and ISO guidelines,按照FDA和ISO医疗器械制造标准下从事协调,执行,测试和写作工艺和设备验证议定书和报告书, Designing, executing, and analyzing experiments based on statistical techniques;developing, troubleshooting and refining medical device manufacturing processes and equipment consistent with engineering principles and lean principles,设计,执行和分析实验统计技术的基础上来开发,疑难排解,和改善医疗器械制造工艺和设备,符合工程原则和精益原则, Evaluating proposed improvements to processes and products based on analyses of regulatory requirements, product quality needs, safety, environmental, economics, and operational goals, etc.评估有关建议改进工艺和产品需基于分析相关监管要求,产品质量的需求,安全,环保, 经济,经营目标等Driving the efficient scale-up of manufacturing processes,部门内主要驱动高效规模化的制造过程的人员,Writing procedures, training other associates, and assisting other technical associates.写程序,培训人员,并协助其它技术同仁Requirements / Qualifications要求/资格A degree in Science or Engineering is required. A minimum of 3 years of experience in an engineering capacity in the medical device, pharmaceutical, or food industry is required.科学或工程学位(大专视为同等)是必需的。至少需要3年相关经验,在医疗设备,医药, 戓食品行业内。 Excellent written, oral and presentation skills are required.出色的书面,口头和表达技巧是必需的。 A work style of hands-on involvement with all phases of his/her projects实际参与工作作风 Demonstrated ability to prioritize, initiate, and drive projects to completion,需在优先次序,启动和驱动项目/计划完成上展示工作能力 knowledge of the fundamentals of statistics (SPC, Minitab…..)需有基本统计知识(如SPC,Minitab.....)Ability to work effectively in team situations as well as independently,有能力在团队情况下或独立运作下都能有效地开展工,demonstrated excellent communication skills, both written and oral (in Chinese/ mandarin). Able to read English (It is a big plus, if the candidate can read and write English)在书面和口语(普通话)展现出色的沟通能力。需能阅读英文.(如果应征者能阅读英文及写英语- 优先考虑) Working knowledge of GMP and ISO 9000 requirements.了解GMP和ISO9000的要求。 职能类别: 医疗器械研发

联系方式

泰州市中国医药城

公司信息

“SCION MEDICAL LIMITED(赛昂国际医疗控股有限公司)总部设立于中国香港,赛昂(上海)医疗器械有限公司Scion Medical Technologies (Shanghai) Ltd.是其中国区运营总部。赛昂医疗目前在中国的生产基地分别位于江苏泰州中国医药城和杭州两地,专注于医疗器械产业的发展,建立起较为成熟的技术研究和产品研发体系,生产运行稳定,已通过ISO 13485医疗器械质量体系认证,产品主要涉及微创介入诊疗设备、植入性高端耗材以及生物医用材料等领域。 公司的发展宗旨是以中国为根基,结合中国本土市场优势、发挥国际技术和金融资源优势,不断引进和创新微创介入诊疗技术,努力提供更多高品质的医疗器械产品,造福广大患者。同时与中国微创介入界广大专家、学者携手合作,努力为微创介入医学事业搭建国际化的学术交流桥梁。 公司的部分在研产品已分别获得美国FDA批准、欧洲CE认证以及中国CFDA产品注册。”

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