上海招聘

JOB RESPONSIBILITIES

工作职责

1. 负责洁净室环境及产品初始污染菌测试和监控

Responsible for clean room environment testing and monitoring

2. 负责实验室培养基配制和验证等实验室日常工作

Responsible for media preparation and verification as well as routine job

3. 负责实验室设备验证

Responsible for micro lab equipments qualification

4. 负责环氧乙烷灭菌日常周期审核

Responsible for EO cycle review

5. 协助完成材料评估

Assist localization parts bio evaluation

6. 负责化学测试和纯化水测试

Responsible for chemical testing and RODI water testing

7. 协助完成验证工作，QMS 定义的其他职责

Assist microbiologist on validation work, and other tasks defined in QMS

WORK ENVIRONMENT

工作环境

- Base in shanghai plant 常驻工厂

- Can work in clean room and lab condition 可以在洁净室和实验室工作

JOB QUALIFICATIONS

岗位资质

1. Knowledge / Education 教育背景

Diploma and above;

大专及以上

Bachelor degree on biological is plus

本科生物相关专业优先

2. Job Experience 工作经验

Rich experience on micro testing in college or one year experience on micro testing. Familiar with environment control and product testing

本科阶段拥有丰富的微生物测试经验，或工厂微生物检测经验，了解环境控制和产品测试。

3. Skills / Competencies 技术能力

Knowledge of microbiological and testing skills

具备微生物学知识和测试机能

4. Credential 证书

Honest and hard working. Good communication skill

诚实，工作努力。良好的沟通能力。

5. Language / Computer 语言/ 计算机能力

Good English skill at writing and reading. Good computer skill

良好的英语读写能力，良好的计算机能力

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.