Systems Engineer

Accuray; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

Accuray is seeking a Systems Engineer in Madison, WI to design, develop and test medical device systems that integrate hardware, software, and safety requirements. You will translate stakeholder needs into system requirements and guide risk management activities.

You will collaborate with hardware and software teams, define test strategies for integration testing, V&V and manufacturing, and support service efforts. Some travel may be required.

Qualifications

• URS and SyRS requirements must be identified and documented
• Familiarity with image-guided and intensity-modulated RT regulatory standards
• Experience collaborating with hardware/software engineers and R&D Physics
• Knowledge of ISO 14971 risk management processes
• Ability to lead system integration planning and testing strategies

Responsibilities

• Understand stakeholders and ensure their needs are properly documented and regarded throughout the program
• Interpret applicable regulatory requirements and standards for image-guided and intensity-modulated radiation therapy
• Identify, analyze, and document URS and SyRS requirements and allocate them to subsystems
• Collaborate with hardware/software engineers and R&D Physics to define system design and workflows
• Drive risk management activities per ISO 14971 and develop related risk controls
• Lead system integration planning and resolution of high-level issues
• Develop test strategies for Integration Testing, Verification & Validation (V&V), Manufacturing and Service

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 makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.Job DescriptionAn 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 ResponsibilitiesUnderstand 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 StatementAt 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.