北京招聘

Description - (Enter the key activities of the role) 填写职位的主要责任

The System Engineer - Regulatory hold the core technical responsibility for Product Creation. This role is responsible for delivering regulatory compliance requirements and breaking down to the product development. As part of System Engineering group, helps the product development teams respond to new or changing laws, standards and regulations for their products.

“Responsibilities and HIRING Requirements 职责和录用条件” (Using e.g. bullet points, identify the detailed aspects and specific responsibilities of the role.


- Communicate and liaise with Regulatory Affairs team to maintain awareness of changing regulations, standards and customer requirements. Analysis of those and link to product compliance requirements such that conformity assessments demonstrate compliance of regulations.
- Understand and interpretation of regulations and standards to product development teams. Develop design guidance to assist product development teams.
- Working with external agencies / test laboratories in delivering a product that constantly meets world-wide IEC /EMC/Safety standards.
- Identify and report any compliance concerns and take immediate corrective action as required during the product life cycle.
- Share domain expertise, knowledge and experience to integrate between the regulation, law, or standard and the requirements definition for peer groups in project team and functional areas.
- Plan and maintain progress in improving personal professional competence.

Relevant Knowledge, skills and competEncies - (For the role, specify the following: - educational background and knowledge, - details of relevant experience, - skills required for the role, - key performance competencies that are required)
相关知识， 技能和能力要求。以上“职责和录用条件”要求之外，并要求以下：

- System Engineers are highly able and experienced individuals with a strong track record of design and development of complex, real-time electromechanical products in a strongly commercial environment.
- They are natural communicators and team players with a passion for their technology; able to communicate at different levels of the company and across the globe.
- Demonstrable experts in their particular technology, with good appreciation of Electronics, Mechanics, or Physics disciplines.
- Bachelor degree or above in relevant engineering or other similar scientific disciplines.
- Excellent knowledge of current best practices for engineering processes, tools, and techniques.
- Fluent in English; some international travel will be required.
- Experience of leading and managing small teams and achieving results.
- Experience in a cross-functional development environment.
- Experience of R&D in a regulated environment(preferable medical device)
- Knowledge of complex electro-mechanical system theory and practice.
- Good understanding of the related standards, e.g. IEC60976/977, IEC60601-2-1, IEC60601-1, EMC, etc.
- Good commercial & business awareness.

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. Elekta provides intelligent and resource-efficient technologies that improve, prolong and save patient lives.
To join ELEKTA team you will work in a highly motivated group with more than 60 years of experiences in medical device. Has the chance to recognize people from different countries in the world and feel the open/aggressive company culture by yourself. You will also be able to build up a solid basis with the opportunity to show innovation in process enhancement and evolution along with the development of the Medical Device industry. You will have the opportunity to apply your skills and efforts into challenging scientific problems.
医科达是跨国性医疗技术集团，以关爱人类生命为使命，在癌症和脑部病变治疗领域锐意进取并提供最为先进的临床治疗方案。针对放射治疗和放射外科，公司致力于开发尖端水平的医疗设备和治疗计划系统，同时为整个癌症治疗领域开发优化工作流程的软件系统。医科达创立于1972年， 由瑞典卡罗林斯卡研究所已故的神经外科教授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5000多家医院，每天为超过10万名患者提供诊断和治疗服务。
今天，医科达在全球大约有3300名员工。医科达在中国的员工总数约500人，业务范围涉及研发、生产、采购、物流、销售、客户支持及质量法规等，国内450余家医院是我们的用户。除北京和上海，医科达在广州、成都、重庆设有分支机构。在2011年9月，医科达在全球成功并购核通公司（Nucletron）。
医科达推崇多元文化。我们的员工来自于不同领域有着不同的文化背景，因共同的使命相聚而共同创建了这个积极灵活的组织。我们致力于为所有员工提供机会并使他们充分发挥个人潜能以适应全球化的环境。