Physics Manager / 物理研发经理
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：2013-09-05
- 工作地点：北京-昌平区
- 招聘人数：若干
- 工作经验：三年以上
- 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
To manage and lead a small team supporting clinical validation process and general physics associated to medical linear accelerators
Responsibilities
1.Ensure that the clinical validation aspects of projects are managed within the principles defined in the Product Creation Process procedure, and according to the ELEKTA, PSC EB Department and Clinical Validation and Physics Section quality systems.
2.Ensure conformance with Clinical Validation and Physics Section policy regarding development processes, tools usage, local work instructions, standards and metrics requirements, and re-use.
3.Create, disseminate, monitor and maintain complete and viable validation plans and schedules, involving all project members in the planning and estimation process. Ensure that exceptions to the plans are recorded, assessed and acted upon. Report progress to the Project Manager, or if appropriate the System Verification Manager and R&D Director
4.Ensure that a Validation (or Physics) Plan is defined to meet the requirements of each project, and is agreed with the engineering leader and project manager.
5.Ensure that project documentation is created in a timely manner according to the requirements of the Engineering Lifecycle.
6.Ensure that Validation reports are completed in a timely manner and that they provide clear recommendations as to the release status of the product.
7.Ensure that project sub-teams are defined as appropriate to the project, and that appropriate project personnel are available and allocated to the project:
8.Ensure that project filing requirements are observed.
9.Be familiar with regulatory requirements. Ensure that the management of projects conforms to the requirements defined by the ELEKTA Collation of Quality Systems for Medical Systems. Ensure that products meet IEC, MDD, EMC and other appropriate compliance criteria.
10.Throughout the life of the project, identify and manage risks that might jeopardise successful completion to specification, time and budget. Report major risks to the Project Manager, or if appropriate the System Verification Manager.
11.Participate in Design FMEA's and other risk management activities during the life cycle of the product creation process.
12.Ensure adequate validation of the product, with full traceability through the development life cycle.
13.Ensure that computer platforms, tools for development and test equipment are available and allocated to the project.
14.Identify requirements for training personnel working on the project.
Authorities -
1.Create Test Cases to cover allocated requirements
2.Review allocated test cases for adequacy of test coverage
3.Run and pass or fail allocated test cases
4.Create and sign off Physics/Validation Test Reports
5.Create and sign off Physics/Validation Test Plans
6.Create and delete test sets in Quality Centre
7.Allocate functional resource
8.Approve software release notes
9.Sign for validation readiness
10.Hold and sign staff appraisals
Manage departmental budget as required
Relevant Knowledge, skills and competEncies -
Candidates should have qualifications and skills equivalent to those of the team they are leading plus at least 2 years experience of leadership experience at project level.
In addition they should have management experience with particularly strong competencies for Drive and Leadership
Written and verbal communication in English
Organisational Ability managing own and other peoples time and defining and delegating responsibilities as required
Good knowledge of oncology devices & clinical work flows, 2 or 3 years working experience of radiotherapy in a hospital is desirable or at a similar medical industrial supplier.
Senior level on radiation physics & application, Dosimetry, as well as Monte Carlo modeling.
Master degree on medical physics on nuclear application, PhD is desirable.
To manage and lead a small team supporting clinical validation process and general physics associated to medical linear accelerators
Responsibilities
1.Ensure that the clinical validation aspects of projects are managed within the principles defined in the Product Creation Process procedure, and according to the ELEKTA, PSC EB Department and Clinical Validation and Physics Section quality systems.
2.Ensure conformance with Clinical Validation and Physics Section policy regarding development processes, tools usage, local work instructions, standards and metrics requirements, and re-use.
3.Create, disseminate, monitor and maintain complete and viable validation plans and schedules, involving all project members in the planning and estimation process. Ensure that exceptions to the plans are recorded, assessed and acted upon. Report progress to the Project Manager, or if appropriate the System Verification Manager and R&D Director
4.Ensure that a Validation (or Physics) Plan is defined to meet the requirements of each project, and is agreed with the engineering leader and project manager.
5.Ensure that project documentation is created in a timely manner according to the requirements of the Engineering Lifecycle.
6.Ensure that Validation reports are completed in a timely manner and that they provide clear recommendations as to the release status of the product.
7.Ensure that project sub-teams are defined as appropriate to the project, and that appropriate project personnel are available and allocated to the project:
8.Ensure that project filing requirements are observed.
9.Be familiar with regulatory requirements. Ensure that the management of projects conforms to the requirements defined by the ELEKTA Collation of Quality Systems for Medical Systems. Ensure that products meet IEC, MDD, EMC and other appropriate compliance criteria.
10.Throughout the life of the project, identify and manage risks that might jeopardise successful completion to specification, time and budget. Report major risks to the Project Manager, or if appropriate the System Verification Manager.
11.Participate in Design FMEA's and other risk management activities during the life cycle of the product creation process.
12.Ensure adequate validation of the product, with full traceability through the development life cycle.
13.Ensure that computer platforms, tools for development and test equipment are available and allocated to the project.
14.Identify requirements for training personnel working on the project.
Authorities -
1.Create Test Cases to cover allocated requirements
2.Review allocated test cases for adequacy of test coverage
3.Run and pass or fail allocated test cases
4.Create and sign off Physics/Validation Test Reports
5.Create and sign off Physics/Validation Test Plans
6.Create and delete test sets in Quality Centre
7.Allocate functional resource
8.Approve software release notes
9.Sign for validation readiness
10.Hold and sign staff appraisals
Manage departmental budget as required
Relevant Knowledge, skills and competEncies -
Candidates should have qualifications and skills equivalent to those of the team they are leading plus at least 2 years experience of leadership experience at project level.
In addition they should have management experience with particularly strong competencies for Drive and Leadership
Written and verbal communication in English
Organisational Ability managing own and other peoples time and defining and delegating responsibilities as required
Good knowledge of oncology devices & clinical work flows, 2 or 3 years working experience of radiotherapy in a hospital is desirable or at a similar medical industrial supplier.
Senior level on radiation physics & application, Dosimetry, as well as Monte Carlo modeling.
Master degree on medical physics on nuclear application, PhD is desirable.
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
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