
Systems Engineer
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Job overview
An Accuray Systems Engineer analyzes, designs, develops, and tests medical device systems, integrating hardware, software, reliability, regulatory compliance, and safety requirements. The role translates stakeholder needs into design inputs, leads risk management under an ISO 14971-compliant process, and guides integration and testing of radiation therapy products, subsystems, and software applications for verification and validation and customer delivery.
Skills & qualifications
Skills
Full job description
JOB REQUIREMENTS: 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 makestreatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Job Description An Accuray Systems Engineer (SE) analyzes, designs, develops and tests medical device systems to ensure the integration of hardware, software, reliability, regulatory compliance, and safety requirements: An SE translates the needs of various business functions (e.g., Marketing, Operations, Service, Regulatory, etc.) into design inputs for the other development teams. SE leads risk management activities via an ISO 14971 compliant risk management process. And SE guides the integration and integration testing of Accuray's radiation therapy products, subsystems, and software applications to ensure high quality design outputs are provided for formal V&V and ultimately provided to customers. Essential Duties and Responsibilities Understand the point of view of product stakeholders (including end users, Marketing, Service, Regulatory, Quality Control, Manufacturing, Service, etc.) and ensure that they are properly documented and regarded throughout the program. Understand and interpret the various applicable regulatory requirements and standards for image-guided radiation therapy and intensity-modulated radiation therapy. Identify, analyze, and document requirements for User Requirements Specification (URS) and System Requirements Specification (SyRS), along with their allocation down to the contributing subsystems. Collaborate with development teams-e.g., hardware and software engineers, subsystem owners, R&D Physics-in defining and documenting system design, operational scenarios and workflows. Drive and participate in risk management activities-e.g., hazard identification and risk assessment, along with the development of related risk controls. Lead system integration planning and execution, facilitating resolution of critical system-level issues across the project. Collaborate with subsystem owners to develop test strategies and methods to support Integration Testing, Verification & Validation (V&V), Manufacturing, and Service. Infrequent travel may be required-e.g., technical visits... For full info follow application link. We are an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/0F9EA7180D4D4D63
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