上海招聘

  

1. To prepare methods and protocols for Clean Room Validation, Sterilization validation, Test Method Validation and Microbial equipment qualification including finish validation protocol, lead execution and reports for divisional review.

   编写草案，实施洁净室验证，灭菌验证，测试方法验证和微生物实验设备验证，包括完成草案，领导执行，并提交分部审阅。

2. Set up test procedure/methods

   建立测试流程和方法

3. Finish routine testing timely and follow up deviations found from routine testing

   按时完成日常工作，对日常的测试偏差进行跟踪

4. Responsible for localization parts bio evaluation process

   负责本地化原材料的评估过程

5. Well maintain testing record/reports

   良好保存记录/报告

6. Initiate procurement of supplemental material for microbial testing

   采购实验耗材

7.  Train bio-technician

   培训技术员

8. Be responsible for data collection, maintain high quality system and drive any improvement accordingly

   负责收集数据，维护良好的质量系统并启动相应改善活动

9. Comply with Company’s EHS policies, regulations and procedures   遵守公司的各项EHS政策、规定和程序

                                  

柯惠医疗器材制造（上海）有限公司即美敦力上海工厂（SMF）是美敦力在华独资的***家生产企业，成立于2006年11月，于2007年4月正式启用。公司坐落于漕河泾高科技园区，总投资4000万美金，总建筑面积达18，414平方米。其中10万级洁净车间面积为3000平方米，实验室总面积为500平方米。公司员工总数近340名，现生产产品16个品种，包括心脏瓣膜、医用高频仪器设备，腹部外科手术器械，手术室、急救室、诊疗设备及器具。
Medtronic Shanghai Manufacturing Facility (SMF) is Medtronic’s first wholly-owned manufacturing subsidiary in China. The site was founded in November 2006 and officially inaugurated in April 2007. With an initial investment of 40 million USD, SMF boasts a gross floor area of 18,414 square meters in Caohejing Hi-Tech Park. The site is composed of 3,000 square meters with Class-8 clean room and 500 square meters for laboratory use. There are currently 340 employees and 16 product lines producing
tissue heart valves, high-frequency medical equipment, abdominal surgery instruments, and diagnostic/treatment instruments used in the operation room and first aid.

公司每年平均引入1-2种新产品投入生产。2014-2015年与美敦力中国研发联手，成功推出基于微波消融技术的肝癌手术设备和新一代血管闭合与组织融合先进电外科设备。2016年公司更以1300万美元的投资额引入美敦力全球***的事业部-心脏业务集团的心脏瓣膜项目，以造福先天性心脏病、风湿性心脏病、冠心病、
心律失常或瓣膜退化、以及心脏血管病变等患者。2017年公司开始正式生产心脏瓣膜产品，预计每年将能够帮助中国和全球的65000名患者更及时地获得高品质的治疗。
SMF continuously expands its local manufacturing capabilities by adding one or two new products to its portfolio per year in average. In 2014 through 2015, collaboration between SMF and Medtronic China Technical Center successfully drove launches of the ablation technology based hepatic surgery devices and new generation of advanced electrosurgical instruments for vessel sealing and dividing. In 2016, 13 million USD was invested in SMF’s further evolvement to introduce the new tissue heart valve manufacturing line for the Medtronic Cardiac Vascular Group. The tissue heart valve material will contribute to helping patients who suffer from congenital, cardiovascular, coronary and rheumatic heart diseases. Starting 2017, the combination of our local and global heart valve manufacturing will help 65,000 patients improve their access to high-quality treatment in China and around the world.

美敦力上海工厂(SMF)致力于成为全球共享制造基地及区域性业务战略伙伴，提供世界一流品质的产品和服务，坚持人才培养，实现员工价值。
The Medtronic Shanghai Manufacturing Facility (SMF) is dedicated to becoming the global shared manufacturing site and regional business strategic partner that provides world class quality products and services, investing in talent development and realizing individual value for our employees.