邹女士
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- 职位介绍
- 医疗器械研发
- Summary: Systems Engineers analyze, design, develop and test medical device systems to ensure the integration of hardware, software, reliability, regulatory compliance, and safety requirements. Systems Engineers serve as contributing members of the Systems Engineering group responsible for the design and development of not only the overall radiation delivery system of the product, but also the subsystems which comprise it. Subsystems include: • Control systems • Electrical power conditioning and distribution • High Voltage pulsed power • S-band microwave power generation and transmission • High energy X-ray generation and collimation • Radiation detection and monitoring • Kilovoltage imaging • Data acquisition and signal processing • Closed-loop water system for temperature control Essential Duties and Responsibilities: • Product Development o Understand the point of view of the user (including End User, Marketing, Service, Regulatory, Quality Control, Manufacturing, Service, etc.) and ensure that they are properly regarded throughout the program. o Understand and interpret the various applicable regulatory requirements and standards for image-guided radiation therapy and intensity modulated radiation therapy. o Drive and participate in hazard identification and risk assessment, along with the development of related risk controls. o Collaborate with subsystem owners to develop system test strategies and methods to support Verification & Validation (V&V), Manufacturing, and Service, lead system integration. o Drive and participate in Engineering Design Change. o Facilitate resolution of critical system level issues across the project. o Support engineering risk management activities, and program and operational process improvements. o Support project planning, scheduling, cost estimating, etc. • Documentation o Identify, analyze, and document requirements for User Requirements Specification (URS) and System Requirements Specification (SyRS), allocate to the lower-level system elements and FMEA capability. o In charge of Design History File to ensure it compliance with GMP, ISO13485 and China regulatory requests. o Establish CAMT engineering team’s development process, to be the owner of Design Control SOP & Product Development Process (PDP) SOP, keep the SOPs up-to-date. o Engineering representative to participate in audits. Qualifications: a. Required • Master’s degree in medical physics, Electrical Engineering, Biomedical Engineering or closely related discipline at least 5 years experiences in a technical discipline. • Knowledge of systems, hardware, and software engineering processes for the development of complex systems including System and Software Architecture, System Analysis, System Integration and Test, and Requirements Management. • Solid knowledge of ISO 13485, ISO 14971, GMP and China regulatory related to imaging and radiotherapy delivery systems • Must have working level knowledge and experience on engineering design change and change control board coordination. • Demonstrated ability to work in a technology development environment as it relates to project management, problem management, and change management. • Excellent troubleshooting and problem-solving skills. • Effective communication skills in English, Chinese, and boundaryless behavior, ability to present ideas clearly and concisely. • Proficient computer skills, including standard office software. • A motivated, organized, and collaborative work style b. Preferred or Desired • An advanced technical degree is a plus. Suitable work experience in a technically related field may be considered in lieu of formal education. • Experience in system modeling. • Experience with advanced computer data analysis software.
- 其他信息
- 语言要求：英语
- 行业要求：全部行业
- 所属部门：Engineering
公司简介
中核安科锐由美国安科锐（ACCURAY, NASDAQ: ARAY）和中国核工业集团中国同辐股份有限公司（01763.HK）共同出资成立，目前拥有射波刀CyberKnife®放射外科手术机器人系统和TomoTherapy® 螺旋断层放射治疗系统，未来将在中国提供集肿瘤精准放射治疗、科技研发、生产及服务全系统解决方案。公司于2019年1月28日签署战略合资协议，同年3月正式成立中核安科锐（天津）医疗科技有限责任公司。秉承患者为先的理念，强强联合，以高起点、高度认同、高度联合、 高新平台、高效协同以及高端服务等六高定位为发展方向，定位于服务中国及世界肿瘤患者，提供更有效、安全、人性化的治疗方案和服务。
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