Systems Engineer
Accuray
Summary
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.
Job description
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.
Requirements
- Must be authorized to work in the country on a permanent basis without sponsorship
- Ability to interpret regulatory requirements and standards for image-guided radiation therapy and intensity-modulated radiation therapy
- Experience documenting User Requirements Specification (URS) and System Requirements Specification (SyRS)
- Experience with risk management activities including hazard identification and risk assessment
- Experience leading system integration planning and execution
- Experience developing test strategies for Integration Testing, Verification & Validation (V&V), Manufacturing, and Service
- Ability to collaborate with cross-functional teams including hardware and software engineers, subsystem owners, and R&D Physics
Company overview
Accuray Incorporated is a leading radiation oncology company that develops, manufactures, and sells innovative tumor treatment solutions designed to set the standard of care in cancer therapy. Founded in 1990 and headquartered in Sunnyvale, California, with additional operations in Madison, Wisconsin, the company specializes in precise radiation therapy and radiosurgery technologies. Accuray's flagship products include the CyberKnife System, a fully robotic radiosurgery platform capable of delivering stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) with sub-millimeter accuracy, and the TomoTherapy Systems, including the next-generation Radixact System, which provide image-guided intensity-modulated radiation therapy (IG-IMRT) using a ring gantry CT scanner platform. These complementary technologies enable clinicians to deliver advanced treatments while minimizing side effects and maximizing patient comfort. The company's systems are used worldwide to treat various cancers, including prostate, lung, brain, spine, liver, pancreas, and kidney tumors. Accuray focuses on expanding the curative power of radiation therapy to help patients live longer, better lives through non-invasive, precise treatment options that require no anesthesia and are performed on an outpatient basis.