北京招聘

Systems Engineer

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:

· 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

· Collaborate with hardware and software engineers, subsystem owners, Marketing, Medical Physics, and Clinical Applications in defining and documenting system design, operational scenarios and workflows

· Create and document the functional architecture that identifies system functions and their interactions.

· Establish and manage key technical performance measures of the system architecture

· Identify, analyze, and document requirements for User Requirements Specification (URS) and System Requirements Specification (SyRS) and allocate to the lower level system elements

· Drive and participate in hazard identification and risk assessment, along with the development of related risk controls

· Understand and interpret the various applicable regulatory requirements and standards for image-guided radiation therapy and intensity modulated radiation therapy

· Collaborate with subsystem owners to develop system test strategies and methods to support Verification & Validation (V&V), Manufacturing, and Service

· Facilitate resolution of critical system level issues across the project

· Collaborate with hardware and software engineers and subsystem owners to define and analyze interfaces between system elements (both internal & external environments)

· Lead system integration project tasks

· Perform trade studies and conduct decision analysis review to ensure balanced designs

· Partition, budget, and model system behavior including simulation analysis and operational modeling

· Collaborate with cross-functional teams on Design-for-X to ensure system is optimally designed

· Support engineering risk management activities, and program and operational process improvements

· Support project planning, scheduling, cost estimating, etc.

· Research sub-system function and design, generate sub-system procurement/performance specifications, and Generate/ execute sub-system qualification tests

· Review internal and external user documentation, and expert-level troubleshooting to resolve internal and external user issues with the radiation delivery system

· Tasks and priorities are project-driven and may be individual or cross-functional

· Infrequently, travel may be required, including technical visits to key vendors or support visits to customer sites

Qualifications:

a. Required

· Bachelor’s degree in Engineering or Physics and at least 5 years of design and development in a highly regulated industry.

· 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.

· Working level knowledge of system and interface specifications

· Demonstrated ability to work in a technology development environment as it relates to project management, problem management, and change management.

· Basic understanding of control systems, electronics, and computer networks.

· Excellent troubleshooting and problem-solving skills.

· Good verbal and written communication skills.

· 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.

· Proficient requirement management skills, including IBM DOORS.

· Experience in system modeling is a plus.

· Experience with advanced computer data analysis software is a plus.

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（********）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。公司成立后植根中国产业发展，共同开创了中国科技服务与创新的全新模式，合力助推国家科技创新与产业转型升级。