北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发管理人员招聘

Project Safety Engineer /项目安全工程师

医科达(上海)软件研发中心

  • 公司规模:50-150人
  • 公司性质:外资(欧美)
  • 公司行业:计算机软件

职位信息

  • 发布日期:2012-08-23
  • 工作地点:北京-昌平区
  • 招聘人数:若干
  • 工作经验:一年以上
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位类别:医药技术研发管理人员  

职位描述

DESCRIPTION 职位描述
The Safety Engineer ensures that the Elekta safety process is applied effectively to the project. The Project Safety Engineer provides a co-ordinating and facilitating role to ensure safety tasks on the project are completed and that safety is central to all the teams’ activities. While the Safety Engineer shares responsibility for safety with the project team, the Safety Engineer’s expertise on safety related matters is expected to take the lead in the group producing safe products.

RESPONSIBILITIES 具体职责
The Safety Engineer has the following responsibilities:
Project work:
? Planning safety activities appropriate to the size of the project and commensurate with the risk from the intended use and characteristics of the product.
? Ensure that the planned activites are applied effectively throughout the project.
? Ensure suitable techniques are applied to analyse design and design changes to identify hazards, causes of hazards and estimate their risk and record the evidence of this analysis
? Ensure appropriate risk control measures are applied to reduce the risk from hazards to an acceptable level.
? Review the safety activities for completeness and effectiveness and prepare a safety case on behalf of the project team that argues activities for the project have sufficient progress and risk is acceptable to release the product. Where the risk is not accepted by the project team, provide the Project Steering Group with the information necessary to make an informed decision regarding release.
Post Production Assessment:
? Perform risk assessment on problems on released products reported through Customer Feedback Reporting Process
Process improvement:
? Use expertise to support process improvement activities to respond to changes in standards, and improve the efficiency of the safety assessment process.
? Assit senior safety engineer to create hazard database of product hazard analysis

AUTHORITIES 岗位权力
? Creation and review of risk assessments resulting from Customer Feedback Reports
? Creation of Safety Risk Management Plans and Reports
? Addition to and review of Product Hazard Analysis in the Hazard database

RELEVANT KNOWLEDGE, SKILLS AND COMPETENCIES 相关知识, 技能和能力要求
Knowledge:
? Risk Management policy and principals; Risk Management processes; Usability principles and procedures; Safety standards, preferably including IEC 61508; Sector specific knowledge is desirable, including ISO 14971, IEC 60601.
Educational:
? No specific requirement, typically 1st degree in science or engineering.
Experience:
? Applying Hazard Identification and Risk assessment methods as part of a development process; Creating risk assessments on systems (preferably both software and hardware); Report writing; Document reviews; Design reviews.
Personal skills:
? Good communication, in particular through documentation and report writing; Analytical and logical; Commitment to complete assignments and ability to work as part of a team; Able to use initiative, remain objective, escalate and seek advice as appropriate.

公司介绍

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders.

Elekta is a high technology medical device company working with the latest technology and tools within the development of software, electronics and hardware. Our manufacturing site has recently seen major investment in the latest tools and processes required to provide an efficient manufacturing process.

Elekta was founded in 1972 by the late Lars Leksell, Professor of Neurosurgery at the Karolinska Institute in Stockholm, Sweden. Today, Elekta solutions in oncology and neurosurgery are used in over 5,000 hospitals globally, and every day more than 100,000 patients receive diagnosis, treatment or follow-up with the help of a solution from the Elekta Group.

Elekta employs around 2,500 employees globally. The corporate headquarter is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker EKTAB.
Elekta has two legal entities, one JV, and one branch organization in China with functions of R&D, Engineering, Manufacturing, Purchasing, QA/RA, and other support functions.

Legal Entities: Elekta (Shanghai) Instruments Ltd, located in Shanghai and Beijing; Shanghai Elekta Oncology Systems Ltd, located in Shanghai
Joint Venture: Elekta BMEI (Beijing) Medical Equipment Co. Ltd, located in Beijing
Branch organization: CMS Worldwide Corp. Shanghai Rep. Office, located in Shanghai. CMS is the software development division responsible for software development around the world within the Elekta Groups

Elekta’s culture values diversity. By combining different traditions and backgrounds of all our employees we can create a positive and flexible organization.

We provide the opportunity and support to enable individuals to use their competencies to develop within a global environment.

Join us, by working together we can fight serious disease and enhance quality of life.

医科达 AB (公众)公司在华独资及合资企业

医科达 AB (公众)公司是跨国性医疗技术集团,总部设在瑞典斯德哥尔摩,并在斯德哥尔摩证交所上市。医科达 AB (公众) 公司是 医科达北研(北京)医疗器械有限公司、医科达上海软件研发中心(美国希迈仕国际公司上海代表处)、医科达(上海)医疗器械有限公司、以及上海医科达放疗设备有限公司的母公司。

医科达 AB (公众)公司在华独资及合资企业主要经营放疗和神经外科两大类产品,包括直线加速器及其相关附属产品,致力于建立本地化的研发、生产和技术支持,为客户提供更完善的服务。我们在此虚位以待,邀您共创中国放疗和神经外科的未来。

公司地址
北京:北京市昌平科技园区创新路21号,
上海:上海市浦东新区世纪大道1528号 陆家嘴基金大厦5F、3F 301, 上海市浦东新区金海路1000号B1

联系方式

  • 公司网站:http://www.elekta.com
  • 公司地址:上海市浦东新区世纪大道1528号 陆家嘴基金大厦5F、3F 301
  • 邮政编码:200122