Physics Manager /物理研发经理
医科达北研（北京）医疗器械有限公司
- 公司规模：50-150人
- 公司行业：计算机软件
职位信息
- 发布日期：2013-11-16
- 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
- 职位类别：其他
职位描述
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.
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.
公司介绍
医科达创立于1972年， 由瑞典卡罗林斯卡研究所神经外科教授Lars Leksell创建成立。医科达总部设在瑞典斯德哥尔摩，并在斯德哥尔摩证交所上市（股票EKTAB）。医科达在肿瘤学、神经外科以及相关网络软件方面的解决方案已应用于全球6000多家医院，每天为超过10万名患者提供诊断和治疗服务。
作为一家具有人文关怀使命的公司，医科达始终致力于癌症和脑部疾病治疗的创新及临床解决方案，用智能、高效的科学技术和设备，改善病人的生活质量，延长及挽救患者的生命。我们寻求的不仅是合作，而是以信赖为基础并拥有共同愿景的长期合作关系，为医护工作者及患者带来更多的信心。在治疗癌症和脑疾病方面，医科达具有很强的作为行业先驱的历史，是现代癌症治疗的创始者。我们的许多产品在全球市场已经取得了第一名，包括：医科达系统神经科学，医科达近距离的治疗方案和系统软件。
中国是医科达的第三大市场。无论是安装直线加速器的台套数，还是治疗计划系统地新增销售量的角度来看，公司在中国都拥有着市场领先地位。在三甲医疗机构中有十分之七配备着医科达的设备。在中国，医科达以超过50%的总的市场份额占据主导地位。
2006年，医科达与北京医疗器械研究所合资，成立医科达北研（北京）医疗器械有限公司， 简称BMEI。目前BMEI已成为医科达一个最重要的产品供应中心。BMEI拥有自己的市场，销售，售后服务，研发，生产制造和采购部门，具有Compact产品的完整业务链。目前BMEI的 200 余名研发及技术人员在这里自主研发和生产着一个自主的产品品牌——Compact，即紧凑型医用电子直线加速器系统，已经广泛应用于国内外医院中，为患者提供肿瘤治疗服务。
BMEI地处昌平科技园区，实行朝九晚五的工作制，中午提供免费午餐，早晚免费班车接送员工。除了法定节假日外，根据司龄的不同，员工每年还享有10-15天的带薪休假及带薪病假。法定五险一金外，BMEI还为员工投保了商业保险，包括意外伤害险和补充医疗保险。工作之余，公司组织了各种活动，篮球俱乐部、羽毛球俱乐部每周定期组织活动，足球比赛、爬山、采摘等活动不定期举办。
医科达是一家全球化公司。BMEI与医科达英国有很多共同承担的项目，员工有很多机会与外籍同事一起工作，也有很好的机会去国外工作。医科达为员工设计了技术、管理双通道的职业发展路径，完善的内部转岗和晋升机制保障了员工的发展通道畅通。近年来，随着医科达净销售额迅速增长，盈利能力迅速并且不断的加强，越来越多的发展机会将提供给我们的员工。
作为医疗器械行业的一员，医科达肩负着伟大的使命。癌症是全球范围内仅次于心血管疾病的第二个导致死亡的主要原因。目前每年约有1.27千万人患有癌症。根据世界卫生组织的报告，预计到2020年，全世界癌症病例估计增长到约1.7千万。未来我们将面临更大的挑战，真诚希望有志于人类健康事业的有识之士加入我们，为挽救患者的生命，提高病人的生活品质共同努力。
作为一家具有人文关怀使命的公司，医科达始终致力于癌症和脑部疾病治疗的创新及临床解决方案，用智能、高效的科学技术和设备，改善病人的生活质量，延长及挽救患者的生命。我们寻求的不仅是合作，而是以信赖为基础并拥有共同愿景的长期合作关系，为医护工作者及患者带来更多的信心。在治疗癌症和脑疾病方面，医科达具有很强的作为行业先驱的历史，是现代癌症治疗的创始者。我们的许多产品在全球市场已经取得了第一名，包括：医科达系统神经科学，医科达近距离的治疗方案和系统软件。
中国是医科达的第三大市场。无论是安装直线加速器的台套数，还是治疗计划系统地新增销售量的角度来看，公司在中国都拥有着市场领先地位。在三甲医疗机构中有十分之七配备着医科达的设备。在中国，医科达以超过50%的总的市场份额占据主导地位。
2006年，医科达与北京医疗器械研究所合资，成立医科达北研（北京）医疗器械有限公司， 简称BMEI。目前BMEI已成为医科达一个最重要的产品供应中心。BMEI拥有自己的市场，销售，售后服务，研发，生产制造和采购部门，具有Compact产品的完整业务链。目前BMEI的 200 余名研发及技术人员在这里自主研发和生产着一个自主的产品品牌——Compact，即紧凑型医用电子直线加速器系统，已经广泛应用于国内外医院中，为患者提供肿瘤治疗服务。
BMEI地处昌平科技园区，实行朝九晚五的工作制，中午提供免费午餐，早晚免费班车接送员工。除了法定节假日外，根据司龄的不同，员工每年还享有10-15天的带薪休假及带薪病假。法定五险一金外，BMEI还为员工投保了商业保险，包括意外伤害险和补充医疗保险。工作之余，公司组织了各种活动，篮球俱乐部、羽毛球俱乐部每周定期组织活动，足球比赛、爬山、采摘等活动不定期举办。
医科达是一家全球化公司。BMEI与医科达英国有很多共同承担的项目，员工有很多机会与外籍同事一起工作，也有很好的机会去国外工作。医科达为员工设计了技术、管理双通道的职业发展路径，完善的内部转岗和晋升机制保障了员工的发展通道畅通。近年来，随着医科达净销售额迅速增长，盈利能力迅速并且不断的加强，越来越多的发展机会将提供给我们的员工。
作为医疗器械行业的一员，医科达肩负着伟大的使命。癌症是全球范围内仅次于心血管疾病的第二个导致死亡的主要原因。目前每年约有1.27千万人患有癌症。根据世界卫生组织的报告，预计到2020年，全世界癌症病例估计增长到约1.7千万。未来我们将面临更大的挑战，真诚希望有志于人类健康事业的有识之士加入我们，为挽救患者的生命，提高病人的生活品质共同努力。