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Job Description

SUMMARY

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.

REPORTING TO/DEPARTMENT

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

ESSENTIAL DUTIES AND RESPONSIBILITIES

Regulatory & Certification Management

• 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.

Design for Compliance & Safety

• 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.

Risk Management & Systems Engineering

• 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.

Standards Monitoring & Implementation

• 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.

Cross-Functional Collaboration

• 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.

Documentation & Compliance Support

• Develop and maintain technical documentation required for regulatory submissions and audits.

• Support investigation and resolution of nonconformances, deviations, and field issues related to safety or compliance.

REQUIRED QUALIFICATIONS

• Bachelor's degree in electrical engineering, systems engineering, or related field.

• 7+ years of experience in medical device, healthcare technology, or similarly regulated industries.

• Demonstrated expertise with IEC 60601-1 and applicable collateral and particular standards.

• Direct experience obtaining CE Mark and/or NRTL approvals for complex electromechanical systems.

PREFERRED QUALIFICATIONS

• Advanced degree in electrical engineering, systems engineering, or related field.

• Experience working within ISO 13485 and FDA Quality System Regulation environments.

• Familiarity with global regulatory frameworks including EU MDR and FDA submissions.

• Experience working directly with notified bodies and certification agencies.

• Experience translating regulatory and safety requirements into engineering requirements and design inputs.

• Strong knowledge of risk management methodologies including FMEA, hazard analysis, and fault tree analysis.

• Experience developing or managing system-level requirements, traceability, verification planning, and design reviews.

• Experience supporting multidisciplinary product development programs.

• Understanding of embedded systems, firmware interactions, and system architecture principles.

• Strong troubleshooting, technical writing, and cross-functional communication skills.

WORKING CONDITIONS

• Indoor Environment: The position takes place indoors, providing a comfortable and climate-controlled workspace.

• Physical Demands: This role may involve standing or walking for extended periods of time, requires manual dexterity and the ability to handle delicate, high-value equipment. Ability to lift and carry equipment or materials required.

• Work Schedule: Standard working hours are Monday through Friday; however, evening, weekend or other work outside normal business hours and overtime may be required.

• Computer Usage: Proficiency with computers, including software applications and communication tools, is essential for tasks and collaboration.

• Personal Protective Equipment: Must wear appropriate personal protective equipment (PPE) and ahere to safety protocols and cleanliness standards.

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.