Systems Engineer

Accuray Incorporated; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Accuray Incorporated is seeking a Systems Engineer to analyze, design, develop, and test medical device systems, ensuring hardware, software, reliability, regulatory compliance, and safety requirements are met. The role translates business needs into design inputs for development teams and guides risk management and integration testing of Accuray’s radiation therapy products and software.

The position involves collaboration with multiple functions, adherence to ISO 14971 risk management, and

Qualifications

• Ability to understand stakeholder perspectives (marketing, operations, regulatory, quality, manufacturing, service) and document requirements accordingly.
• Familiarity with image-guided radiation therapy and intensity-modulated radiation therapy standards.

Responsibilities

• Understand stakeholder viewpoints and ensure they are documented and considered during the program.
• Interpret regulatory requirements and standards for image-guided and intensity-modulated radiation therapy.
• Identify and document User Requirements Specification and System Requirements Specification and allocate to subsystems.
• Collaborate with hardware and software engineers, subsystem owners, and R&D Physics in defining system design and workflows.
• Lead risk management activities, including hazard identification and risk assessment, and develop related controls.
• Lead system integration planning and resolve critical system-level issues across the project.
• Collaborate with subsystem owners to develop test strategies for Integration Testing, V&V, Manufacturing, and Service.
• Occasional travel for vendor visits or customer support.

Job description

Give hope. Give health. Make your mark in the fight against cancer.

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makestreatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

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.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.