Senior 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.Job DescriptionSUMMARY: The Senior Compliance Engineer is responsible for ensuring that all products and subsystems meet global regulatory, safety, and compliance requirements throughout the product lifecycle. This role partners cross-functionally with Engineering, Quality, Regulatory Affairs, and Manufacturing to proactively design for compliance, manage certification activities, and sustain approvals in a highly regulated medical device environment.Reporting To/DepartmentReports to the Director, Systems Engineering in the Systems Engineering & Applied Science departmentEssential Duties And ResponsibilitiesRegulatory & Certification ManagementMaintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvalsPlan, coordinate, and oversee all required compliance testing activities, including engagement with external test labs and certification bodiesLead submissions, responses, and issue resolution with notified bodies and regulatory agenciesSupport regulatory filings and product registrations by providing required compliance documentation and technical justificationsDesign for Compliance & SafetyProvide input to system and subsystem design requirements to ensure alignment with IEC, EN, UL, and other applicable standardsOversee implementation of safety features across electrical, mechanical, and system-level designsOwn safety-related hardware aspects, including insulation coordination, creepage/clearance, environmental robustness, and user interaction safetyEnsure compliance considerations are embedded early in product development to minimize rework and certification riskRisk Management & AnalysisLead and facilitate risk management activities, including FMEA, fault tree analysis, and hazard analysis in accordance with ISO 14971Identify gaps against regulatory standards and drive mitigation plans to closureTranslate risk and compliance findings into actionable engineering requirementsStandards Monitoring & ImplementationMonitor changes in global regulatory and safety standards and assess impact to existing and future productsDevelop and execute plans for timely implementation of standard updatesServe as a subject matter expert on medical electrical equipment standards (e.g., IEC 60601 series) Cross-Functional CollaborationPartner with Quality, Regulatory, and Manufacturing teams to ensure compliant, repeatable, and manufacturable designsProvide compliance guidance to engineering teams throughout the development lifecycleSupport internal audits, external inspections, and remediation effortsMentor junior engineers and contribute to building organizational capability in compliance engineeringDocumentation & Compliance SupportDevelop and maintain technical documentation required for regulatory submissions and auditsEnsure accurate traceability between requirements, risk controls, verification, and validation activitiesSupport investigation and resolution of nonconformances, deviations, and field issues related to safety or complianceCore CompetenciesPersonal ExcellenceEffective in communication, demonstrates professionalism at all times, and has an accurate picture of selfStrengthening the TeamDemonstrates high performance standards and effectively collaborates with the team, demonstrates a sense of ownership over assigned deliverables, and shows a high degree of motivation toward achieving individual and team goalsDrive for ResultsApplies financial discipline and a good business sense, supports change, and makes high quality and timely decisionsRequired QualificationsBachelor’s degree in Electrical Engineering or related discipline7+ years of experience in medical device, healthcare technology, or similarly regulated industryDemonstrated expertise with IEC 60601-1 and applicable collateral and particular standardsDirect experience obtaining CE Mark and/or NRTL approvals for complex electromechanical systemsStrong knowledge of risk management methodologies (FMEA, hazard analysis, fault tree analysis)Experience designing and evaluating safety features in electrical and system-level designsAbility to interpret and apply regulatory and safety requirements to engineering design decisionsStrong troubleshooting and root cause analysis skillsExcellent documentation and technical writing skillsEffective communication and collaboration skills across technical and non-technical stakeholdersPreferred Or DesiredAdvanced degree in Electrical Engineering or related fieldExperience working within ISO 13485 and FDA Quality System Regulations (21 CFR Part 820) environmentsFamiliarity with global regulatory frameworks (e.g., EU MDR, FDA submissions)Experience working directly with notified bodies or certification agenciesProficiency in schematic design and understanding of embedded systems and firmware interactionsExperience supporting audits, inspections, and regulatory findingsProject management experience leading cross-functional initiativesWORKING CONDITIONSIndoor 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 StatementAt 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.