Systems Engineer

Accuray; Deming (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Accuray develops, manufactures and sells radiotherapy systems and software that enable safer, shorter and more personalized cancer treatments. The Systems Engineer will analyze, design, and test complex medical device systems, ensuring regulatory compliance and safety throughout the product lifecycle.

Collaborating with hardware, software and R&D teams, the role requires leading risk management activities, documenting URS/SyRS, and guiding integration testing and V&V to deliver high-quality

Qualifications

• Essential duties reflect responsibilities for a Systems Engineer in medical devices.

Responsibilities

• Analyzes, designs, develops and tests medical device systems to ensure hardware, software, reliability, regulatory compliance, and safety requirements.
• Leads risk management activities via an ISO 14971 compliant process.
• Guides integration and testing of Accuray’s radiation therapy products, subsystems, and software for V&V and customer delivery.
• Understands stakeholder perspectives and documents requirements for URS and SyRS.
• Collaborates with hardware and software engineers, subsystem owners, and R&D Physics to define system design and workflows.
• Drives and participates in risk management activities and develops related controls.
• Leads system integration planning and resolves critical system-level issues.
• Develops test strategies with subsystem owners to support Integration Testing, V&V, Manufacturing, and Service.
• Some travel may be required; ability to work in the country without sponsorship.

Job description

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.

Essential Duties and Responsibilities

• 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.


• 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.

Our Vision and Mission

We work passionately to expand the curative power of radiation therapy to improve as many lives as possible. We pursue this by thinking, acting, and executing beyond expectations every day to deliver better, safer radiation therapy solutions and help patients get back to living their lives, faster.

Powerful Innovation that Delivers

We are committed to designing radiotherapy solutions that can take on the most complex challenges — while making commonly treatable cases even easier. From robotic to helical radiation therapy delivery, we invent unique, market-changing solutions that can meet the full spectrum of patient needs.