Systems Engineer, Medical Devices: Shape Safer Cancer Care

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

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