广东恒健核子医疗产业有限公司（英文简称HJH）是广东恒健投资控股有限公司设在广州的一家中外合资公司。 公司在顺德投资85亿元，建设质子和重离子肿瘤治疗技术产业化项目。 质子和重离子肿瘤治疗技术处于相关行业的产业链前端环节，属于广东省拟重点发展的战略性新兴产业，在国内乃至世界上处于领先地位。 公司将逐步建成集药物、质子和重离子肿瘤治疗装置生产中心、培训中心、治疗中心、花卉和食品辐照等产业为一体的研发及生产基地，自身可实现产值1000多亿元，并带动大型精密机加工、超导磁铁设计制造、真空束运系统、医用机器人、X光与数位影像处理、控制盘、电源供应器、高能仪表、质子摄影机、正电子摄影机、呼吸监控、治疗计划系统、辐射防护等相关配套产业，填补国内在相关产业的空白，对国家乃至地区的发展具有战略意义。
随着公司的高速发展，我们诚邀有抱负、有责任感、有志者共同续写HJH的辉煌明天。
有意者可通过以下方式投递简历：A、发邮件至：hjhhr@gdhjh.com；B、邮寄： 广州市天河路45号天伦大厦16楼 广东恒健核子医疗产业有限公司 人力资源部收，邮编：510060（请在信封左下角注明应聘职位）。 应聘者资料保密，恕不退回。合则约见，勿访勿电。公司将为员工提供完善的薪资、福利和广阔的个人发展空间，我们真诚期待您的加入。
【链接】
广东恒健投资控股有限公司是广东省属投资控股公司。公司近两年来先后完成了珠三角城际轨道建设项目发行募集100亿中票资金、投资10亿元参与中航通用珠海产业基地建设、投资5亿元参与深圳市第8.5代薄膜晶体管液晶显示器件(TFT-LCD)生产线项目建设等诸项重大工作。恒健投资的战略发展目标是成为最大的省级投融资平台、高科技企业的孵化器和旗舰。
http://hengjian.toprand.net/index.aspx
Director of QA& Compliance 质保与法规总监
(See below for English version)
职位综述：
质保与法规总监负责领导和发展整体的质量组织结构。职位持有人负责法规管理下的医疗产品的生产和测试，确保医疗产品遵守所有适用的监管和合同的要求。他/她与不同的的内部人员,承包商,供应商和客户打交道。对于擅长在自主、快节奏下工作、具有领导才能和高度的组织技能的人才，这是一个非常好的机会。
职位持有人将侧重于三个方面：
1. 质量管理体系: 为公司和相关的项目建立和维护质量管理体系。
2. 产品/项目质量保证: 符合相关法律 、法规要求的项目和产品质保管理运作
3. 作为一个环境、健康和安全(EHS)顾问,在所有辐射安全、环保、健康、安全的事项方面代表公司, 组织贯彻执行法规要求和公司的EHS管理规章制度和流程。
任务和责任
1. 为质量保证(QA)体系的开发和实施提供领导和指导，提升和管理负责质量管理体系的人员。
2.就有关法规适用条例所需的流程、 程序和质量标准提供战略指导。
3. 管理医疗产品的设计、 开发和生产经营质量。
4.对所有进程、 资格、验证报告、控制文件的更改、 产品和系统的调查、 技术报告 （包括质量管理、 研发等） 和质量调查等作出的审查和认可进行批准或监督。
5. 管理临床试验的质量监测。
6. 建立每年 QA 管理目标和相关的执行行动计划。
7. 与相关人员沟通交流并为推进每年的QA目标实施和审核工作提供必要的培训。
8. 为各项活动 （例如生产许可证和产品注册） 制定法规事务处理/策略。
9. 及时指导、 培养和支持项目小组（场地管理、 项目管理）质量方针政策工作，确保必要的后期跟进。
10. 确保对审计和监管结果采取适当的改进措施。
11.执行复杂的业务项目验证和验证管理
12. 收集和发布行业内监管、 专利及发展趋势方面的信息
13. 执行正式的对内部或对选定供应商的风险评估和FMEA( 故障类型与理象分析) ；确定审计的时间间隔，并建立风险水平。
14.做现场合规检查和审计之间的联系人。
人员要求：
1.技术/工科/工程专业学士学位以上， 硕士或博士学位优先。
2.10年相关医疗设备的质保和法规 经理/总监级经验，15 年医疗器械行业经验。
3.拥有制造工程与管理方面的实践经验。
4.熟悉中国医疗设备管理法规和政策。
5.直接参与管理国家药监局和 ISO规章审核经验。
6.具备医疗设备软硬件开发的质量控制程序方面的知识。
7.拥有申领国家药监局医疗器械注册和生产许可证的成功经验。
8.具备选择和使用质量工程工具和技术的能力。
9.能熟练解释并应用国内和国际相关法规和行业标准 （例如 CGMP、ISO、QSR、IEC、UL等）。
10.具有极强的中英文沟通和表达能力。
11.具有在快速变化的环境中管理多个不同项目任务的能力。
12.客观的观察能力和解释法规风险的能力。
13.具有直接与监管卫生当局进行审查批准前和批准后沟通协调的成功经验。
14.领导和影响跨部门员工以保证合规的能力
15.质量认证工程(CQE)和/或质量认证审核员(CQA)优先
JOB SUMMARY
The Director of Quality Assurance and Compliance shall lead and develop the overall quality organization. The successful candidate will be responsible for Quality Assurance for regulated medical product manufacturing and testing operations. The candidate will assure that medical products are conducted in compliance with all applicable regulatory and contractual requirements and will interact with a diverse set of internal staff, contractors, vendors, and clients. This is an excellent opportunity for an individual with highly developed organizational skills who thrives in an entrepreneurial, fast-paced environment, and excels in leadership roles.
The candidate will focus on three aspects:
1. Quality management system: establishment and maintenance of the quality management system for the Company and related projects.
2. Product/Project QA: being an operational QA Manager for Project and product QA management for the purpose of regulatory compliance
3. Act as an Environment, Health and Safety (EHS) advisor to represent the Company on all radiation safety, environmental, health, and safety matters which are established according to regulatory requirements and company EHS policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Provide Quality Assurance (QA) leadership and direction for the development and implementation of Quality Systems. Develop and manage personnel overseeing quality and compliance.
2. Provide strategic direction regarding processes, procedures and quality standards required to maintain compliance to applicable regulations.
3. Manage quality oversight of medical product design, development, and manufacturing operations.
4. Approve or oversee review and approval on all processes, qualifications and validation reports, change control documents, product and systems investigations, technical reports (including QC, R&D, etc) and quality investigations.
5. Manage quality monitoring of clinical trials.
6. Establish the yearly QA management objectives and the associated implementation action plans
7. Communicate and provide necessary training to the related parties the QA Objectives implementation and review progress of the yearly action plans
8. Define Regulatory Affairs approach/strategy in their respective activities (e.g. production permit and product registration)
9. Coach, train and support the stakeholders (site management, project management) the quality policy and procedures when needed, ensure necessary follow-up
10. Ensure that appropriate corrective actions are taken as a result of audit observations and monitoring activities.
11. Perform complex operational projects verification & validation management
12. Collect and publish industry information in regulation, patent and development trend
13. Perform formal internal risk assessments and FMEA as well as with selected contract providers; determine audit intervals and establish level of risk.
14. Act as point of contact for on-site regulatory inspections and audits.
QUALIFICATIONS
1. Minimum of a bachelor degree in a technical/scientific/engineering discipline, an MS or PhD degree is desirable.
2. Ten years of relevant medical device experience in quality assurance and compliance at the Manager/Director level, and 15 years of total experience in the medical device industry.
3. Hands-on experience in manufacturing engineering and management are required.
4. Familiar with medical equipment regulation and policy in China,
5. Experiences in directly managing regulatory audits by SFDA and ISO are desired.
6. Knowledge in development quality control procedures for medical devices software and hardware.
7. Successful experiences of the SFDA procedures for medical equipment registration and manufacturing permit application.
8. Competence in the selection and use of Quality Engineering Tools and Techniques.
9. Strong knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. cGMP, ISO, QSR, IEC, UL, etc.)is necessary.
10. Excellent interpersonal, verbal, and written communication skills in both Chinese and English.
11. Ability to manage multiple and varied tasks in a fast-moving environment
12. The ability to objectively observe processes and interpret compliance risks is required.
13. Direct hands-on experience in successfully interacting with regulatory health authorities at pre- and post-approval inspections.
14. Ability to lead and influence cross functional employees to ensure regulatory compliance.
15. Certified Quality Engineering (CQE) and/or Certified Quality Auditor (CQA) is a plus.
Project Management Director 项目管理总监
(See below for English version)
职位综述 ：
该职位是为了支持公司的质子治疗业产化任务而设。职位持有人全面负责具有多样化技术要求的工程项目，确保其按照进度和预算完成。他/她负责提出项目技术性及成本可行性的立项报告书，整合、 管理、 激励和领导多学科的技术团队成功完成项目。作为项目各小组的协调人，他/她直接与客户打交道，提供实时、直接、完整、可行的意见反馈给他人，在尽可能减少冲突或分歧的情况下解决分歧。他/她为管理层提供及时的项目进展报告。
任务和责任
1. 执行项目进度计划和重大事件，设置清晰的项目发展蓝图。
2. 负责对项目进度进行跟踪并向管理层和相关方提供和及时报告。
3. 带领多元化的技术团队按进度成功开展项目。确保与管理层及相关部门进行清晰的沟通,将需求要求传达到管理层及相关部门。
4. 协调可用的资源，并确定不直接可用的资源，为管理层准备并提交项目状态汇报。
5. 可能监督其他职位，完成业绩评估。
6. 指导来自不同团队的项目团队成员，负责提出项目技术性及成本可行性的立项报告书。
人员要求
1. 工程项目管理学士学位，MBA 毕业者优先。
2. 10 年以上大型工程、 开发或建设项目经验。
3. 以团队为基础的环境下领导项目的经验和能力。
4. 领导要求符合药监局 GMP/QSR，ISO 9001、13485标准的项目经验。
5. 有效的人际交往能力，优秀的口头和书面沟通技巧。
6. 利用项目管理工具（如 MS 程序与 MS Office） 的能力。
7. 能讲流利的英语和汉语。
8. 具备财务、 质量管理、 运营以及物流的一般常识。
9. 具备管理交叉功能及多元文化团队的能力。
10. 阅读、分析和翻译最复杂的文件的能力。
11. 对敏感的询问或投诉作出有效反应的能力。
12. 能在管理层和客户面前做有效的、有说服力的演讲和演示。
13. 利用创新的技术和风格写文章或讲话。
14. 能够定义问题，收集数据，查明事实，并有效做出结论。能用数学或图表形式解释各种技术指令，处理各种抽象和具体的变量。
Job Summary
This job is created to support the Proton Therapy industrialization task of the company. The job holder is expected to be fully responsible for ensuring projects with diversified engineering requirements are completed on schedule and budget. The job holder creates project proposals, both technical and cost. He / She assembles, manages, inspires and leads multi-disciplined technical teams to successfully complete projects. He/She will act as the liaison for project teams and interacts directly with the customer. He / She provides current, direct, complete and actionable feedback to others and settles differences with minimum conflict or disruption. He/ She provides the Management timely project status reports.
Job Description
1. Perform project scheduling and milestone setting to have a clear roadmap of the project
2. Be responsible for project progress tracking and timely reports to management and the related parties
3. Leads multi-disciplined technical teams to succeed project on time on schedule. Ensures clear communication and need requests are reached to the management and related parties
4. Coordinate available resources and identify resources not directly available. Prepares and delivers comprehensive and understandable project status reports to management
5. May supervise other positions and complete performance evaluations.
6. Directs a variety of project team members. Responsible for the creation of project proposals, both technical and cost.
Person Specification
1. Bachelor degree in engineering project management, MBA preferred.
2. Minimum 10 year experience leading engineering, development or construction projects.
3. Established experience and ability to lead projects in a team-based environment.
4. Experience with leading projects requiring compliance with SFDA GMP/QSR, ISO 9001, 13485.
5. Effective interpersonal skills and excellent oral and written communication skills.
6. Ability to utilize project management tools such as MS Project, and the MS Office.
7. Fluent in both Chinese and English
8. General knowledge in finance, quality control, operations and logistics
9. Skills in managing teams of cross function & multiple cultures
10. Ability to read, analyze, and interpret the most complex documents.
11. Ability to respond effectively to the most sensitive inquiries or complaints.
12. Ability to write speeches and articles using original or innovative techniques or style.
13. Ability to make effective and persuasive speeches and presentations to management and customers.
14. Ability to define problems, collect data, establish facts, draw valid conclusions, interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Director of Electrical Engineering 电子电机工程部总监
(See below for English version)
职位综述
负责管理团队的电子电机工程师。通过管理人员或管理组织，雇用、 提高和挽留团队内必需的支持项目的工程师。作为技术管理带头人, 职位持有人要确保员工团队技能、实践、过程和工具能够胜任电子电气工程领域所要求的质量和结果。职位持有人将经常参加产品开发项目中的项目节点的技术评估。他/她根据需要经常对所有项目的技术进展进行监督，如果重新定向时，确保没有重大工程延误。职位持有人必须能够跨越多个部门有效地管理资源和项目，以便在有限的时间框架下交付成品。作为技术管理团队的关键成员，职位持有人须具备与公司内所有技术及业务部门有效工作和沟通的能力，按照不断变化的工作重点、项目影响和技术需要做出及时调整并完成所有的任务。
任务和责任
1. 管理电气工程各项活动，确保质量、 进度和预算目标的实现：
n 开发新的有关设计、 测试、 集成和安装的概念和技术，专注于本领域和相关科学。
n 执行设计、 测试、 集成和安装工作，与项目团队的目标和要求保持一致。
n 与项目组内其他专业成员协调（包括项目组长、机械工程、现场服务、软件工程、技术记录、医师和技师等）
n 开发创新概念和技术，包括有专利潜力和出版可能的想法
n 保证项目开发计划务实， 既考虑了要求，又考虑了风险和问题
n 保证项目开发的支出和日程与项目的复杂性和风险相匹配
2. 生成项目建议和/或计划，对新产品或已有产品进行开发
3. 及时向管理层提供电气工程项目任务进度情况
4. 为团队成员提供持续的、积极的反馈。根据绩效评估方法为每个团队成员准备并提交准确的绩效考核反馈
5. 确保团队成员熟悉正确的操作制度和工作方法
6. 对于有新的开发要求、要大幅修改工程技术方法、或需要某种特殊知识的复杂项目，能及时完成。解释并评估结果以决定其有效性和科学意义
7. 定义项目的范围和关键因素并选择解决方法
8. 按照需要参加跨部门战略团队，定义并计划技术和产品方向
9. 直接或间接督导工电气程团队，作为技术领头人充当其它工程师的导师
10. 通过定期的员工会议、小组沟通会、电子邮件和其它的安全沟通方式保证团队内部不同级别的沟通
11. 为电气工程团队的总体职能和项目的成功负责任
人员要求
1. 电气工程专业学士学位或同等相关的学位，更高的学位优先。
2. 10年以上印制电路板的设计、射频系统、电路级设计与仿真、高电压技术、 信号处理和电气工程设计实践经验， 5 年以上电气工程团队管理领导经验。
3. 通过制造模拟或数字设计将概念转化为制造的实践能力。
4. 优秀的规划和组织技能。
5. 具有经验或资质，可执行须经药监局GMP/QSR或ISO 13485认证通过的项目
6. 要求有将 Matlab、 Mathmatica 等与高端EDA 工具一起使用的经验。
7. 拥有良好的开发实时数据采集和监控的经验，有控制系统经验者更佳。
8. 必须具有在复杂系统环境下设计和应用控制系统结构的知识和经验。
9. 具备核工程和/或电子知识和经验者尤佳。
10. 具有在快节奏的多变环境中根据技术趋势开发未来创新产品记录者尤佳
11. 拥有细分工作、 确定优先事项、 资源分配、 解决问题、 决策和影响力的能力。
12. 必须能够清晰有效地向团队成员以口头或书面的方式表达信息
13. 能够阅读、分析、诠释一般科技杂志和文件。能够对常见的询问或投诉做出回答
14. 熟悉概率和统计归纳等数学概念及平面/立体几何学和三角学基础
15. 能够定义问题，收集数据，查明事实，并做出有效结论。
16. 用数学或图表形式解释各种广泛的技术指令的能力，能够处理多种抽象和具体的变量。
17. 将逻辑或科学思维的原则应用于广泛的知识和实际问题的能力。
18. 处理最艰涩状态下的非语言符号 (公式、 科学方程、 图形等） 的能力
19. 成功的候选人须具有优秀的写作和组织能力，能够有效地记录项目的每个状态
JOB SUMMARY
This role is responsible for the managing a team of electrical and electronic engineers. Either directly or through the management organization within the team, this individual will hire, develop, and maintain the staff of engineers necessary to support the project work assigned to the team. This role is expected to serve as the lead technical authority for the team and to insure that staff skills, practices, processes, and tools specific to the electronic and electrical engineering fields are adequate and will result in quality work and outcomes. This individual will frequently participate in technical reviews for project milestones within product development projects. Oversight of technical progress on all projects is expected as often as is needed to insure that redirection takes place when needed and without significant project delays. This Director must be able to effectively manage resources and projects across multiple software development teams in order to deliver product under aggressive timeframes. As a key member of the technology management team, the Director must be able to effectively work with and communicate to all technical and business groups in the company, adapt to shifting priorities, estimate project impacts and technical needs, and deliver on all commitments.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage all aspects of electrical engineering activities and ensure objectives for quality, schedule and budget are achieved:
n Develop new design, test, integration, and installation concepts and techniques in this field and related sciences.
n Execute design, test, integration, and installation tasks in accordance with project team objectives and requirements.
n Coordinate tasks with the other specialist project team members (including the team leader, mechanical, field service, and software engineers, technical writers, scientists, physicians, and technologists).
n Develop innovative concepts and techniques including ideas that are worthy of patenting or publishing.
n Ensure project development plans realistically address risks and problems as well as requirements.
n Ensure project development costs and schedules are commensurate with project complexity and risks.
- Generating project proposals and/or plans for new or existing product development.
- Ensures electrical engineering project task status updates are provided to project management teams in a timely manner as appropriate.
- Provides continuous employee feedback to team members, focusing on positive feedback. Prepares and delivers accurate performance reviews for each team member in accordance performance evaluation guidelines.
- Ensures team members are familiar with the appropriate operating policies and work instructions to perform their duties and responsibilities.
- Completes complex projects that require development of new or highly modified engineering or scientific techniques and procedures, extensive knowledge of specialty. Interprets and evaluates results to determine their validity and scientific significance.
- Define scope and critical elements of projects and selecting approaches to be taken.
- Participate as needed on cross-functional, strategic teams that define and plan technology and product directions.
- Directly and indirectly supervises the Electrical Engineering team and perform as a technical leader mentoring other engineers.
- Ensure that appropriate business communications are cascaded to the employees within the team via regular staff meetings, group communication meetings, e-mail and other secured communication methods.
- Accountable for overall success of Electrical Engineering functions and projects.
QUALIFICATIONS
- Bachelor degree in Electrical Engineering or equivalent related degree required, advanced degree preferred.
- Must have at least 10 years hands-on experience with PCB design, RF system, circuit level design and simulation, high voltage technique, signal processing, and understanding of the electrical engineering design process with at least 5 years of team leadership and management in electrical engineering team are required.
- Demonstrated abilities in analog and/or digital design from conceptual stages through manufacturing are required.
- Highly developed planning and organizational skills are required.
- Experience or receive certification with leading projects requiring compliance with FDA GMP/QSR of ISO 13485 is desired.
- Experience using high end EDA tools along with Matlab, Mathmatica and MathCad is required.
- Proven track record of developing scientific instrument real-time data collection, monitoring, and control systems are preferred.
- Must have knowledge and experiences in control system architecture design and implementation in complex system environment.
- Knowledge and experiences in nuclear engineering and/or electronic is a plus.
- Have a track record of innovation creating new products for the future in tune with technology trend in a fast-paced, agile environment is highly desired.
- Understanding of approaches to work breakdown, prioritization, resource allocation, problem solving, decision making, and influencing is valuable.
- Must be able to present information clearly and efficiently between team members verbally and in writing.
- Ability to read, analyze, and interpret common scientific and technical journals and documents. Ability to respond to common inquiries or complaints.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases
- The successful candidate must have excellent writing and organizational skills and be able to efficiently document every state of a project.
Director of Mechanical Engineering机械工程部总监
(See below for English version)
职位综述
本职位负责管理机械工程师团队，通过直接管理或管理团队内部的架构，职位持有人招聘、发展并留住项目工作必须的工程师人才。职位持有人作为团队的技术带头人，要保证在机械工程领域必需的人员技能、实践、流程和工具处在充足和高质的状态。职位持有人需经常参与产品开发项目的项目技术和全面进程评估，以保证在必要时做战略的更改却不耽误项目的进程。职位持有人必须能够跨越多个部门有效地管理资源和项目，以便在有限的时间框架下交付成品。作为技术管理团队的关键成员，职位持有人须具备与公司内所有技术及商务部门有效工作和沟通的能力，按照不断变化的工作重点、项目影响和技术需要做出及时调整并完成所有的任务。
任务和责任
1. 管理机械工程活动的所有方面，保证实现质量、进程和预算目标：
· 开发本领域和相关学科在设计、测试、整合和安装方面的新概念和技术
· 根据项目团队的目标和要求执行设计、测试、整合和安装任务
· 与项目组内其他专业成员协调（包括项目组长、电机工程、现场服务、软件工程、技术记录、医师和技师等）
· 开发创新概念和技术，包括有专利潜力和出版可能的想法
· 保证项目开发计划务实， 既考虑了要求，又考虑了风险和问题
· 保证项目开发的支出和日程与项目的复杂性和风险相匹配
2．领导设计、安装、测试、交接、更新校准、预防性维护及公司系统和产品验证等各个方面
3. 生成项目建议和/或计划，对新产品或已有产品进行开发
4. 及时向管理层提供机械工程项目任务进度情况
5. 为团队成员提供持续的、积极的反馈。根据绩效评估方法为每个团队成员准备并提交准确的绩效考核反馈
6. 确保团队成员熟悉正确的操作制度和工作方法
7. 对于有新的开发要求、要大幅修改工程技术方法、或需要某种特殊知识的复杂项目，能及时完成。解释并评估结果以决定其有效性和科学意义
8. 定义项目的范围和关键因素并选择解决方法
9. 按照需要参加跨部门战略团队，定义并计划技术和产品方向
10. 直接或间接督导机械工程团队，作为技术领头人充当其它工程师的导师
11. 通过定期的员工会议、小组沟通会、电子邮件和其它的安全沟通方式保证团队内部不同级别的沟通
12. 为机械工程团队的总体职能和项目的成功负责任
人员要求
1. 学士学位或以上，专业为机械工程或其它相关类似专业
2. 至少有10年的实地工程经验，包括结构设计、制动系统（马达控制和精密定位）、真空工程、电磁工程、有限元建模和分析
3. 计划、领导过组装、安装工程团队人员，保证产品和系统符合工程设计和客户要求
4. 具有应用诸如科学计算器、MathCad, CosmosWorks, SolidWorks, AutoCAD等工程工具的经验
5. 具有分析诸如客户和产业设计要求、特定指标、标准和手册等数据的经验以便进行可行性分析和开发设计
6. 具有经验或资质，可执行须经药监局GMP/QSR或ISO 13485认证通过的项目
7. 理解任务分段、决定优先、资源分配、问题解决、做出决策和影响他人的方法
8. 必须能够清晰有效地向团队成员以口头或书面的方式表达信息
9. 能够阅读、分析、诠释一般科技期刊和文件。能够对常见的询问或投诉做出回答
10. 熟悉概率和统计归纳等数学概念及平面/立体几何学和三角学基础
11. 成功的候选人须具有优秀的写作和组织能力，能够有效地记录项目的每个状态
JOB SUMMARY
This role is responsible for the managing a team of mechanical engineers. Either directly or through the management organization within the team, this individual will hire, develop, and maintain the staff of engineers necessary to support the project work assigned to the team. This role is expected to serve as the lead technical authority for the team and to insure that staff skills, practices, processes, and tools specific to the mechanical engineering fields are adequate and will result in quality work and outcomes. This individual will frequently participate in technical reviews for project milestones within product development projects. Oversight of technical progress on all projects is expected as often as is needed to insure that redirection takes place when needed and without significant project delays.This Director must be able to effectively manage resources and projects across multiple development teams in order to deliver product under aggressive timeframes. As a key member of the technology management team, the Director must be able to effectively work with and communicate to all technical and business groups in the company, adapt to shifting priorities, estimate project impacts and technical needs, and deliver on all commitments.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage all aspects of mechanical engineering activities and ensure objectives for quality, schedule and budget are achieved:
n Develop new design, test, integration, and installation concepts and techniques in this field and related sciences.
n Execute design, test, integration, and installation tasks in accordance with project team objectives andrequirements.
n Coordinate tasks with the other specialist project team members (including the team leader, electrical,field service, and software engineers, technical writers, scientists, physicians, and technologists).
n Develop innovative concepts and techniques including ideas that are worthy of patenting or publishing.
n Ensure project development plans realistically address risks and problems as well as requirements.
n Ensure project development costs and schedules are commensurate with project complexity and risks.
- Lead aspects of, the design, installations, testing, commissioning, upgrade calibration, preventive maintenance and verification of Company’s systems and products.
- Generating project proposals and/or plans for new or existing product development.
- Ensures mechanical engineering project task status updates are provided to project management teams in a timely manner as appropriate.
- Provides continuous employee feedback to team members, focusing on positive feedback. Prepares and delivers accurate performance reviews for each team member in accordance performance evaluation guidelines.
- Ensures team members are familiar with the appropriate operating policies and work instructions to perform their duties and responsibilities.
- Completes complex projects that require development of new or highly modified engineering or scientific techniques and procedures, extensive knowledge of specialty.Interprets and evaluates results to determine their validity and scientific significance.
- Define scope and critical elementsof projects and selecting approaches to be taken.
- Participate as needed on cross-functional, strategic teams that define and plan technology and product directions.
- Directly and indirectly supervises the Mechanical Engineering team and perform as a technical leader mentoring other engineers.
- Ensure that appropriate business communications are cascaded to the employees within the team via regular staff meetings, group communication meetings, e-mail and other secured communication methods.
- Accountable for overall success of Mechanical Engineering functions and projects
QUALIFICATIONS
- Bachelor degree in Mechanical Engineering or equivalent related degree required, advanced degree preferred.
- Must have at least 10 years hands-on engineering experience in Structural Design; Motion (motor control and precision positioning) Systems; Vacuum Engineering; Electromagnet Engineering; Finite element modeling and analysis.
- Track records in planning and directing engineering personnel in fabrication and installation activities; ensuring products and systems conform to engineering design and customer specifications.
- Experiences in applying engineering tools including scientific calculators, MathCad, CosmosWorks, SolidWorks, AutoCAD.
- Experiences in analyzing data such as customer and industrial design requirements, specifications, standards and manuals to establish feasibility and develop design.
- Experience or receive certification with leading projects requiring compliance with FDA GMP/QSR or ISO 13485 is desired.
- Understanding of approaches to work breakdown, prioritization, resource allocation, problem solving, decision making, and influencing is valuable.
- Must be able to present information clearly and efficiently between team members verbally and in writing.
- Ability to read, analyze, and interpret common scientific and technical journals and documents. Ability to respond to common inquiries or complaints.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- The successful candidate must have excellent writing and organizational skills and be able to efficiently document every state of a project.
Director of Software Engineering 软件工程部总监
(See below for English version)
职位综述：
负责管理软件和固件工程师团队。负责管理团队的工程师。通过管理人员或管理组织，雇用、 提高和挽留团队内必需的支持项目的工程师。作为技术管理带头人, 职位持有人要确保员工团队技能、实践、过程和工具能够胜任软件工程领域所要求的质量和结果。职位持有人将经常参加产品开发项目中的项目节点的技术评估。他/她根据需要经常对所有项目的技术进展进行监督，如果重新定向时，确保没有重大工程延误。职位持有人必须能够跨越多个软件开发团队有效地管理资源和项目，以便在有限的时间框架下交付成品。作为技术管理团队的关键成员，职位持有人须具备与公司内所有技术及业务部门有效工作和沟通的能力，按照不断变化的工作重点、项目影响和技术需要做出及时调整并完成所有的任务。
任务和责任
1. 管理全方面的软件研发，确保项目质量、进度及预算目标的完成。
2. 生成项目建议和/或计划，对新产品或已有产品进行开发
3. 确定项目任务和评估软件开发计划。
4. 确保软件开发任务满足系统要求
5. 为项目管理团队提供及时适当的软件项目状态更新。
6. 为团队成员提供持续的、积极的反馈。根据绩效评估方法为每个团队成员准备并提交准确的绩效考核反馈
7. 确保团队成员熟悉正确的操作制度和工作方法
8. 对于有新的开发要求、要大幅修改工程技术方法、或需要某种特殊知识的复杂项目，能及时完成。解释并评估结果以决定其有效性和科学意义
9. 定义项目的范围和关键因素并选择解决方法
10. 确保在项目团队工程核心团队代表有足够的领导技能
11. 按照需要参加跨部门战略团队，定义并计划技术和产品方向
12. 直接和间接地监督软件工程团队并完成业绩评估。
13. 通过定期的员工会议、小组沟通会、电子邮件和其它的安全沟通方式保证团队内部不同级别的沟通
14. 需要时在核心团队中作软件团队代表。
15. 为软件工程团队的总体职能和项目的成功负责任
人员要求
1. 计算机科学或同等相关的学位学士，计算机技术硕士学位者优先。
2. 10 年以上软件开发方法 （如Agile或 Scrum 软件开发模型） 和理解软件工程的设计实践经验，5 年以上软件工程师团队的领导和管理经验者优先。
3. 拥有丰富以物件为导向的设计和编程范式知识，拥有 UNIX 和 Windows 平台的丰富的 c + + 编程知识。
4. 具备 Java 编程和 J2EE 框架的知识和技能。
5. 具有参与大型的符合药监局GMP/QSR 或ISO 13485 认证要求的项目经验或获得类似证书。
6. 拥有科学仪器实时数据采集、 监视和控制系统经验。
7. 有在复杂系统环境下控制系统结构设计和执行的经验。
8. 具有信息技术开发知识和经验者优先。
9. 具有在快速多变环境下根据技术发展趋势创新产品之经验者优先。
10. 拥有细分工作、 确定优先事项、 资源分配、 解决问题、 决策和影响力的能力。
11. 阅读、 分析和翻译一般科技期刊和文件的能力，对常见咨询或投诉作出回应。
12. 编写操作手册的能力。
13. 熟悉概率和统计归纳等数学概念及平面/立体几何学和三角学基础
14. 应用概念（如分数、 百分比、实际情况比例）的能力。
15. 能够定义问题，收集数据，查明事实，并有效做出结论。
16. 用数学或图表形式解释各种广泛的技术指令的能力，能够处理多种抽象和具体的变量。
17. 将逻辑或科学思维的原则应用于广泛的知识和实际问题的能力。
18. 处理最艰涩状态下的非语言符号 (公式、 科学方程、 图形等） 的能力
19. 解决各种抽象和具体变量的能力。
语言要求
流利的中、英语阅读、 写作和口语能力。
JOB SUMMARY
This role is responsible for managing a team of software and firmware engineers. Either directly or through the management organization within the team, this individual will hire, develop, and maintain the staff of engineers necessary to support the project work assigned to the team. This role is expected to serve as the lead technical authority for the team and to insure that staff skills, practices, processes, and tools specific to the software engineering field are adequate and will result in quality work and outcomes. This individual will frequently participate in technical reviews for project milestones within product development projects. Oversight of technical progress on all projects is expected as often as is needed to insure that redirection takes place when needed and without significant project delays. This Director must be able to effectively manage resources and projects across multiple software development teams in order to deliver product under aggressive timeframes. As a key member of the technology management team, the Director must be able to effectively work with and communicate to all technical and business groups in the company, adapt to shifting priorities, estimate project impacts and technical needs, and deliver on all commitments.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage all aspects of software research and development and ensure objectives for quality, schedule and budget are achieved.
- Generating project proposals and/or plans for new or existing product development.
- Identifies project tasks and estimates for software development efforts.
- Ensures software development tasks meet system requirements
- Ensures software project task status updates are provided to project management teams in a timely manner as appropriate.
- Provides continuous employee feedback to team members, focusing on positive feedback. Prepares and delivers accurate performance reviews for each team member in accordance performance evaluation guidelines.
- Ensures team members are familiar with the appropriate operating policies and work instructions to perform their duties and responsibilities.
- Completes complex projects that require development of new or highly modified engineering or scientific techniques and procedures, extensive knowledge of specialty. Interprets and evaluates results to determine their validity and scientific significance.
- Define scope and critical elements of projects and selecting approaches to be taken.
- Ensure that there is adequate leadership skill within the project team with engineering core team representatives.
- Participate as needed on cross-functional, strategic teams that define and plan technology and product directions.
- Directly and indirectly supervises the Software Engineering team and completes performance evaluations.
- Ensure that appropriate business communications are cascaded to the employees within the team via regular staff meetings, group communication meetings, e-mail and other secured communication methods.
- Serve as the software representative on a core team when needed.
- Accountable for overall success of Software Engineering functions and projects.
QUALIFICATIONS
- BS in Computer Science or equivalent related degree required, MSCS preferred.
- Must have at least 10 years hands-on experience in software development methodologies (such as the Agile or Scrum Software Development model) and understanding of the software engineering design process with at least 5 years of team leadership and management in software engineering team are required.
- Strong knowledge in object-oriented design and programming paradigm, highly experienced in C++ programming on UNIX and Windows platform required.
- Knowledge and skills in Java programming and J2EE framework.
- Experience or receive certification with leading projects requiring compliance with FDA GMP/QSR or ISO 13485 is desired.
- Proven track record of developing scientific instrument real-time data collection, monitoring, and control systems are preferred.
- Must have knowledge and experiences in control system architecture design and implementation in complex system environment.
- Knowledge and experiences in information technology development a plus.
- Have a track record of innovation creating new products for the future in tune with technology trend in a fast-paced, agile environment is highly desired.
- Understanding of approaches to work breakdown, prioritization, resource allocation, problem solving, decision making, and influencing is valuable.
- Ability to read, analyze, and interpret common scientific and technical journals and documents. Ability to respond to common inquiries or complaints.
- Ability to write procedure manuals.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases
- Ability to deal with a variety of abstract and concrete variables.
LANGUAGES
Fluent in Chinese and English reading, writing and speaking.
