Medical Device Systems Engineer – Radiation Therapy

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

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