Sr. Project Engineer
苏州碧迪医疗器械有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2017-04-01
- 工作地点:苏州-工业园区
- 招聘人数:1人
- 学历要求:本科
- 语言要求:英语 精通
- 职位月薪:0.8-1.5万/月
- 职位类别:工程/设备主管
职位描述
职位描述:
KEY RESPONSIBILITIES(主要职责)
1. Work as project leader, setup and manage relative project team member, and report function manager;
做为项目负责人,负责建立和管理所属项目小组,并向所属部门经理报告;
2. Handle project management work, include collect relative information, evaluate process, cost analysis, safety and risk analysis.
负责对项目进行管理,包括收集信息、过程评估、成本分析、安全评估和风险管理;
3. Be responsible for primary phase project budget, and prepare project budget.
负责为编制项目预算的前期准备并编制项目预算;
4. Be responsible for overall project management, and report project status on time.
负责对该项目进行全程管理,并定期汇报工作进展;
5. Managing project team to finish new product input, include new product specification, drawing, gauge/number, traceability/Label and process flow chart etc. setup.
负责领导项目小组完成对新产品引进的产品规格、图纸、规格/编号、标识/标签和工艺流程图的制定;
6. Be responsible for communicate with Regulation Engineer, to make assure project to meet regulation requirement.
负责与法规工程师及时沟通,确保该项目的法规符合性;
7. Be responsible for communicate with purchase Engineer, to make assure relative equipment and raw material supplier’s sourcing, price and other information to match with purchase Engineer.
负责与采购工程师及时沟通,确保相关设备和原材料供应商的选择和价格信息及时传递到采购工程师;
8. Be responsible for relative equipment, tool validation and BOM setup, include IQ protocol and report, OQ protocol and report, PQ protocol and report, relative equipment, tooling etc. log into local document center, and support relative product Engineer to setup relative product technical files.
负责相关设备/模具的验证及BOM的建立,包括:安装验证/报告、操作验证/报告、生产验证/报告,整理/归档设备、模具资料,提高相关资料并协助产品工程师建立相关产品技术资料。
SKILLS AND ABILITIES(技能)
1. University graduate, majored in Engineering, chemical Engineering, Engineering management fielded etc. with 3-5 years’ working experience in MNC or Joint Investment Company;
本科毕业,主修工程专、化学工程、工程管理等相关专业,有3-5年生产型外资企业或合资公司工作经验;
2. Familiar with ISO9001,13485 and GMP criteria;
熟悉ISO9001,13485 和GMP标准;
3. Familiar with Medical, Pharmaceutical or food industry manufacturing process in clean room;
熟悉医疗器械,药物或者食品行业在净化车间的生产过程;
4. Good communication skill with good knowledge of process /project management skill with experience leading cross-functional team or as team or as team member in this type of project team;
具有良好沟通能力,具备工艺或项目管理技能,在跨部门项目中担任过项目负责人或者项目组成员。
5. Good spoken and written English;
良好的英语口语和书写能力
6. Good computer skill;
良好的计算机技能;
7. Working experience with process validation, SPC, DOE, and process 6 Sigma GB/BB will be an advantage;
有工艺验证、SPC, DOE经验和六西格玛绿带或黑带将优先考虑;
8. With MFG working background / environment (molding / assembly / packaging / automation) will be an advantage.
有注塑、装配、包装、自动化等生产经验将优先考虑。
举报
分享
KEY RESPONSIBILITIES(主要职责)
1. Work as project leader, setup and manage relative project team member, and report function manager;
做为项目负责人,负责建立和管理所属项目小组,并向所属部门经理报告;
2. Handle project management work, include collect relative information, evaluate process, cost analysis, safety and risk analysis.
负责对项目进行管理,包括收集信息、过程评估、成本分析、安全评估和风险管理;
3. Be responsible for primary phase project budget, and prepare project budget.
负责为编制项目预算的前期准备并编制项目预算;
4. Be responsible for overall project management, and report project status on time.
负责对该项目进行全程管理,并定期汇报工作进展;
5. Managing project team to finish new product input, include new product specification, drawing, gauge/number, traceability/Label and process flow chart etc. setup.
负责领导项目小组完成对新产品引进的产品规格、图纸、规格/编号、标识/标签和工艺流程图的制定;
6. Be responsible for communicate with Regulation Engineer, to make assure project to meet regulation requirement.
负责与法规工程师及时沟通,确保该项目的法规符合性;
7. Be responsible for communicate with purchase Engineer, to make assure relative equipment and raw material supplier’s sourcing, price and other information to match with purchase Engineer.
负责与采购工程师及时沟通,确保相关设备和原材料供应商的选择和价格信息及时传递到采购工程师;
8. Be responsible for relative equipment, tool validation and BOM setup, include IQ protocol and report, OQ protocol and report, PQ protocol and report, relative equipment, tooling etc. log into local document center, and support relative product Engineer to setup relative product technical files.
负责相关设备/模具的验证及BOM的建立,包括:安装验证/报告、操作验证/报告、生产验证/报告,整理/归档设备、模具资料,提高相关资料并协助产品工程师建立相关产品技术资料。
SKILLS AND ABILITIES(技能)
1. University graduate, majored in Engineering, chemical Engineering, Engineering management fielded etc. with 3-5 years’ working experience in MNC or Joint Investment Company;
本科毕业,主修工程专、化学工程、工程管理等相关专业,有3-5年生产型外资企业或合资公司工作经验;
2. Familiar with ISO9001,13485 and GMP criteria;
熟悉ISO9001,13485 和GMP标准;
3. Familiar with Medical, Pharmaceutical or food industry manufacturing process in clean room;
熟悉医疗器械,药物或者食品行业在净化车间的生产过程;
4. Good communication skill with good knowledge of process /project management skill with experience leading cross-functional team or as team or as team member in this type of project team;
具有良好沟通能力,具备工艺或项目管理技能,在跨部门项目中担任过项目负责人或者项目组成员。
5. Good spoken and written English;
良好的英语口语和书写能力
6. Good computer skill;
良好的计算机技能;
7. Working experience with process validation, SPC, DOE, and process 6 Sigma GB/BB will be an advantage;
有工艺验证、SPC, DOE经验和六西格玛绿带或黑带将优先考虑;
8. With MFG working background / environment (molding / assembly / packaging / automation) will be an advantage.
有注塑、装配、包装、自动化等生产经验将优先考虑。
职能类别: 工程/设备主管
公司介绍
Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
联系方式
- 公司地址:上班地址:苏州园区白榆路5号