高级认证工程师
徕卡显微系统（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械 仪器仪表/工业自动化
职位信息
- 发布日期：2013-05-14
- 工作地点：上海-浦东新区
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：认证工程师/审核员
职位描述
Purpose/Objective:
To ensure the company to comply with all applicable safety standards and regulations (CCC, CSA/UL/TUV and RoHS, etc.). To ensure quality and on time delivery of our products that meet those standards and regulations to the customers.
Area of Responsibilities:
Safety Engineer
?Independent planning, execution and documentation of technical product testing (internal/external) according to Low Voltage Device and EMC directives and in addition CSA / UL approvals.
?Work with development team to develop safety requirement and specification for our products according to all applicable safety standards and regulations.
?Keep up to date with standards/regulations and provide training to the development team on these updated /new standards.
?Establish and maintain relevant processes according to ISO13485-/FDA
?Communicate and cooperate with relevant departments from government to ensure compliance.
V&V Engineer
?As part of the V&V team, he/she also participates in typical verification and validation work. Time split between V&V and safety engineering will depends on project needs.
Person Profile
Essential Qualifications & Education:
?Bachelor degree in Engineering
?Electrical engineering is preferred.
Skills & Knowledge:
?Solid professional knowledge and hands-on experience in relevant standards (such as, 61010 series)
Experience:
?> 5 years of experience in industry, preferably in medical device.
?Hands-on technical experience in product development or testing
?Working experience in Notified Body like UL, TUV, etc would be preferred
Personal Skills / Attributes:
?Good team work spirit and communication skills
Other areas: eg. Language & office skill
?Excellent English (oral/written) is a must
?MS office skill,
To ensure the company to comply with all applicable safety standards and regulations (CCC, CSA/UL/TUV and RoHS, etc.). To ensure quality and on time delivery of our products that meet those standards and regulations to the customers.
Area of Responsibilities:
Safety Engineer
?Independent planning, execution and documentation of technical product testing (internal/external) according to Low Voltage Device and EMC directives and in addition CSA / UL approvals.
?Work with development team to develop safety requirement and specification for our products according to all applicable safety standards and regulations.
?Keep up to date with standards/regulations and provide training to the development team on these updated /new standards.
?Establish and maintain relevant processes according to ISO13485-/FDA
?Communicate and cooperate with relevant departments from government to ensure compliance.
V&V Engineer
?As part of the V&V team, he/she also participates in typical verification and validation work. Time split between V&V and safety engineering will depends on project needs.
Person Profile
Essential Qualifications & Education:
?Bachelor degree in Engineering
?Electrical engineering is preferred.
Skills & Knowledge:
?Solid professional knowledge and hands-on experience in relevant standards (such as, 61010 series)
Experience:
?> 5 years of experience in industry, preferably in medical device.
?Hands-on technical experience in product development or testing
?Working experience in Notified Body like UL, TUV, etc would be preferred
Personal Skills / Attributes:
?Good team work spirit and communication skills
Other areas: eg. Language & office skill
?Excellent English (oral/written) is a must
?MS office skill,
公司介绍
徕卡显微系统（上海）有限公司成立于1995年，是徕卡仪器（德国）有限公司在中国的全资子公司。位于浦东新区金桥出口加工区，其投资总额为1057万美元，注册资本为680万美元，总面积为10,000平米,员工近500人。2005年徕卡正式加入美国丹纳赫（Danaher）集团，成为丹纳赫生命科学及诊断事业部的一个重要分支。
公司目前主要有两大部门：光学显微系统（Leica Microsystems）和组织病理系统(Leica Biosystems)。
光学显微系统(LMS)包括生物显微镜和医学显微镜，规格从低端到高端，主要应用于教学、医学、科技应用及其它光学系统。作为全球显微制造行业中的佼佼者，公司拥有一流的生产设备和团队，同时其研发力量亦日趋增强。
组织病理系统(LBS)的产品涵盖切片机，脱水机，包埋机，染色机及其他实验室设备，覆盖组织学的每个步骤，并为整个实验室提供高效的工作流程方案。以提供最优质、最全面的病理产品为使命，公司在上海不仅建立了完善的装配生产线，同时也组建了强大的研发团队，从而打造适合中国和世界的一流的病理产品。
公司地址：上海市浦东新区金桥出口加工区金藏路258号1号楼。
公司目前主要有两大部门：光学显微系统（Leica Microsystems）和组织病理系统(Leica Biosystems)。
光学显微系统(LMS)包括生物显微镜和医学显微镜，规格从低端到高端，主要应用于教学、医学、科技应用及其它光学系统。作为全球显微制造行业中的佼佼者，公司拥有一流的生产设备和团队，同时其研发力量亦日趋增强。
组织病理系统(LBS)的产品涵盖切片机，脱水机，包埋机，染色机及其他实验室设备，覆盖组织学的每个步骤，并为整个实验室提供高效的工作流程方案。以提供最优质、最全面的病理产品为使命，公司在上海不仅建立了完善的装配生产线，同时也组建了强大的研发团队，从而打造适合中国和世界的一流的病理产品。
公司地址：上海市浦东新区金桥出口加工区金藏路258号1号楼。
联系方式
- 公司网站：http://www.leica-microsystems.com
- 公司地址：浦东新区金藏路258号1号楼 (邮编：201206)
- 邮政编码：201206
- 电话：13795315363