Job Description
An Accuray Systems Engineer (SE) analyzes, designs, develops and tests medical device systems to ensure the integration of hardware, software, reliability, regulatory compliance, and safety requirements: An SE translates the needs of various business functions (e.g., Marketing, Operations, Service, Regulatory, etc.) into design inputs for the other development teams. SE leads risk management activities via an ISO 14971 compliant risk management process. And SE guides the integration and integration testing of Accuray’s radiation therapy products, subsystems, and software applications to ensure high quality design outputs are provided for formal V&V and ultimately provided to customers.
Essential Duties and Responsibilities- Understand the point of view of product stakeholders (including end users, Marketing, Service, Regulatory, Quality Control, Manufacturing, Service, etc.) and ensure that they are properly documented and regarded throughout the program.
- Understand and interpret the various applicable regulatory requirements and standards for image-guided radiation therapy and intensity-modulated radiation therapy.
- Identify, analyze, and document requirements for User Requirements Specification (URS) and System Requirements Specification (SyRS), along with their allocation down to the contributing subsystems.
- Collaborate with development teams—e.g., hardware and software engineers, subsystem owners, R&D Physics—in defining and documenting system design, operational scenarios and workflows.
- Drive and participate in risk management activities—e.g., hazard identification and risk assessment, along with the development of related risk controls.
- Lead system integration planning and execution, facilitating resolution of critical system-level issues across the project.
- Collaborate with subsystem owners to develop test strategies and methods to support Integration Testing, Verification & Validation (V&V), Manufacturing, and Service.
- Infrequent travel may be required—e.g., technical visits to key vendors or support visits to customer sites.
To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.
