Usability Engineer
Date: Jun 5, 2025
Location: Rochester, NY, US
Company: Carestream Health
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Carestream is a worldwide provider of medical imaging systems and solutions; x-ray imaging systems for non-destructive testing; manufacturing of film and precision contract coating services for a wide range of industrial, medical, electronic and other applications—all backed by a global service and support network. Carestream’s diagnostic imaging technology systems are at work in 90 percent of hospitals worldwide.
At Carestream, we offer a global perspective and a world of opportunities for people who have the desire to make a positive impact. Join our global team of 3,000+ professionals!
Compensation: $99,900 to $133,200 per year
*This range reflects Carestream’s good faith estimate to pay fairly as starting wage. Offers will be tailored within the range based on the selected candidate’s experience, industry knowledge, technical and communication skills, and other factors that may prove relevant during the interview process, as well as geographic market differentials for the position.
Position Summary:
We are seeking a skilled Usability Engineer to lead the implementation and enhancement of the Carestream usability engineering process to ensure compliance with industry standards and regulatory requirements. This individual will be responsible for ensuring seamless collaboration, alignment with regulatory requirements, and successful execution of usability engineering deliverables for medical device development. The ideal candidate will have strong interpersonal and organizational skills, experience in usability engineering, and a deep understanding of regulatory standards in a medical device context.
Position Responsibilities:
• Ensure the Carestream usability engineering process complies with IEC 62366-1, ISO 14971, and FDA Human Factors Engineering guidelines.
• Review and update usability templates and process documentation to remain compliant with evolving standards.
• Develop and manage specific Usability Engineering Files (UEFs), ensuring complete and compliant documentation (e.g., usability plans, testing protocols, and reports).
• Conduct usability validation studies, as needed, to ensure device interactions minimize risk and enhance user experience.
• Support the internal team in addressing usability-related risks and integrating findings into development and risk management documentation.
• Provide usability insights throughout the design phase, aligning product decisions with usability objectives.
• Engage clinical teams to incorporate real-world user feedback into usability assessments and device improvements.
Required Skills & Education:
• BS in Engineering, Human Factors, or a related field and 7+ years of experience in usability engineering for regulated industries.
• Excellent communication and organizational skills to manage cross-functional collaboration.
• Strong documentation skills, including experience reviewing and managing usability files.
Desired Skills:
• MS in Human Factors, Engineering, or a related discipline.
• Strong understanding of IEC 62366-1, ISO 14971, and FDA Human Factors Engineering guidelines strongly preferred .
• 10+ years of experience in usability engineering, including working with external usability vendors.
• Proven experience working with external usability agencies or vendors.
Carestream is an Equal Opportunity Employer
Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Applying for a job with Carestream
All applicants must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations
Requisition ID: 4374
Nearest Major Market: Rochester