Senior Systems Engineering Compliance Engineer

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.

Systems Engineers at Accuray analyze, design, develop and test medical device systems to ensure the integration of hardware, software, reliability, regulatory compliance, and safety requirements. A Systems Engineering Compliance Engineer (or just Compliance Engineer) serves as a contributing member of the Systems Engineering team, specifically responsible for maintaining product compliance with global regulatory and safety standards, such as the IEC 60601 family of standards.

As Senior Compliance Engineer, this position is expected to lead submissions, responses, and issue resolution with notified bodies, including CE Mark and NRTL approvals. They also lead by instituting compliance management best practices and lead others in compliance related activities. This role serves as a bridge between systems engineering and compliance, translating regulatory and safety requirements into system requirements, architecture decisions, risk controls, and verification activities.

Reports to the Director, Systems Engineering in the Systems & Applied Science department

• Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvals.
• Plan, coordinate, and oversee compliance testing activities with external test labs and certification bodies.
• Lead submissions, responses, and issue resolution with notified bodies and regulatory agencies.
• Support regulatory filings and product registrations through technical documentation and compliance justifications.

• Provide input to system and subsystem requirements to ensure alignment with IEC, EN, UL, and other applicable standards.
• Evaluate system architectures and design solutions to ensure compliance requirements are appropriately allocated across hardware, software, and subsystems.
• Oversee implementation of safety features across electrical, mechanical, software, and system-level designs.
• Own safety-related design aspects including insulation coordination, creepage/clearance, environmental robustness, and user interaction safety.
• Drive compliance considerations through requirements reviews, design reviews, and architecture reviews.

• Lead risk management activities including FMEA, hazard analysis, and fault tree analysis in accordance with ISO 14971.
• Translate compliance and risk findings into clear, testable engineering requirements.
• Ensure traceability between regulatory requirements, risk controls, system requirements, and verification activities.
• Collaborate with systems engineers to incorporate hazards, risk controls, and compliance requirements into system architecture and verification strategies.

• Monitor changes in global regulatory and safety standards and assess impacts to existing and future products.
• Develop and execute implementation plans for new or revised standards.
• Serve as a subject matter expert on medical electrical equipment standards, including the IEC 60601 family.

• Partner with Quality, Regulatory, Manufacturing, and Engineering teams to ensure compliant and manufacturable designs.
• Support internal audits, external inspections, and remediation efforts.
• Mentor engineers and promote best practices in compliance and systems engineering.