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