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 Description
Company Statement:
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.
SUMMARY:
As a Human Factors Engineer, you will be responsible for ensuring Accuray products are safe, effective, and usable by intended users through human factors engineering, usability testing, and validation of user interfaces and workflows. You will apply a risk-based, user-centered approach to translate use-related risks, user needs, and intended use into human factors plans, protocols, and objective evidence supporting product development and regulatory submissions. Product Test Engineering partners with Systems Engineering, Software Engineering, Hardware Engineering, Clinical, Service, Manufacturing, Quality, Regulatory, and Project Leadership teams throughout the development lifecycle to identify use-related risks early, evaluate designs with representative users, and support successful product releases.
Successful candidates are highly adaptable, user-focused problem solvers who can plan and facilitate rigorous usability studies, observe and analyze user interactions, translate findings into actionable design feedback, and communicate human factors evidence effectively in a regulated medical device environment.
REPORTING TO/DEPARTMENT:
Reports to the Sr Manager, Product Test Engineering
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Human Factors Strategy and Planning: Develop and execute human factors and usability engineering strategies across the product development lifecycle, including formative and summative validation activities.
- Use-Related Risk Analysis: Partner with Systems, Quality, Regulatory, Clinical, and engineering teams to identify critical tasks, reasonably foreseeable use errors, and use-related hazards, and ensure testing addresses the highest-risk user interactions.
- User and Use Environment Definition: Define and document intended users, user characteristics, use environments, workflows, and operational scenarios that inform human factors requirements and study design.
- Formative Usability Testing: Plan, moderate, and document formative evaluations of software, hardware, labeling, alarms, controls, and end-to-end clinical workflows to identify usability issues early and influence design decisions.
- Human Factors Validation: Author protocols and reports and lead summative/human factors validation testing with representative users, realistic use scenarios, and production-equivalent systems to demonstrate that the user interface supports safe and effective use.
- Study Execution and Facilitation: Recruit or coordinate representative participants, develop scenarios and moderator guides, facilitate test sessions, capture observations, and maintain objective study evidence.
- Data Analysis and Design Feedback: Analyze task performance, use errors, close calls, operational difficulties, and qualitative feedback; identify patterns and translate results into clear recommendations for design and risk-control improvements.
- User Interface and Workflow Evaluation: Evaluate complex interactions across software, hardware, accessories, labeling, training, service, and clinical workflows with attention to overall system usability and safety.
- Documentation and Regulatory Support: Maintain traceable human factors documentation and provide human factors evidence and technical input for design reviews, risk management activities, design history file deliverables, and regulatory submissions.
- Cross-Functional Collaboration: Work closely with engineering, clinical, product management, service, quality, regulatory, and Product Test Engineering teams to advocate for user-centered design and resolve human factors findings.
- Continuous Improvement: Advance human factors methods, study templates, lab practices, knowledge sharing, and integration of usability engineering into development processes.
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QUALIFICATIONS:
- Required:
- Bachelor's degree in Human Factors Engineering, Human-Computer Interaction, Psychology, Biomedical Engineering, Industrial Engineering, Systems Engineering, or a related technical field, or an equivalent combination of education and experience.
- 3–5 years of experience in human factors engineering, usability engineering, usability research/testing, medical device development, or a closely related discipline.
- Experience planning, moderating, and documenting usability studies with representative users, including development of study protocols, task scenarios, moderator guides, and reports.
- Strong observational, analytical, and problem-solving skills with the ability to identify use-related issues and translate findings into actionable design recommendations.
- Ability to evaluate complex software, hardware, and workflow interactions from the perspective of intended users and use environments.
- Excellent written and verbal communication skills and the ability to collaborate effectively across cross-functional teams.
- Experience producing technical documentation and objective evidence suitable for formal design and regulatory records.
- Ability to work on-site regularly in our Madison office.
- Preferred or Desired:
- Experience applying human factors/usability engineering within an FDA-regulated medical device environment or other safety-critical regulated industry.
- Working knowledge of FDA human factors guidance and IEC 62366-1 usability engineering principles for medical devices.
- Experience with formative and summative human factors validation testing for complex medical devices or other integrated systems.
- Experience with use-related risk analysis, critical task identification, and traceability between risks, user interface requirements, and validation evidence.
- Experience evaluating software user interfaces, hardware controls, alarms, labeling, training, and end-to-end user workflows.
- Experience working with clinicians, service personnel, or other specialized user populations in simulated or representative use environments.
- Experience supporting regulatory submissions and responding to human factors or usability-related review questions.
- Experience with requirements management, risk management, defect tracking, or study data analysis tools.
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.
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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.