Systems Engineer - Radiation Therapy Medical Device

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

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.