Cyient
Website:
cyient.com
Job details:
Key Responsibilities
Usability Engineering & Compliance
- Define and execute the usability engineering approach across product development, including usability engineering plans.
- Conduct use specification development, task analysis, workflow analysis, and scenario creation.
- Identify hazard‑related use scenarios and contribute to usability risk mitigation and usability FMEA.
- Ensure compliance with IEC 62366‑1, FDA Human Factors Guidance, and Philips internal usability processes.
User Research & Evaluation
- Perform formative usability studies (concept validation, UI prototype testing, workflow evaluations).
- Plan, conduct, and document summative usability evaluations to support regulatory submissions.
- Conduct contextual inquiries with clinicians, technicians, and other healthcare workers to understand clinical use environments.
Documentation & Regulatory Deliverables
- Create HFE documentation including:
- Use specifications
- Task analyses
- Usability risk analyses
- Usability FMEA
- Formative and summative study protocols and reports
- Inputs to the Usability Engineering File
- Compile usability evidence and reports supporting global regulatory submissions.
Cross‑Functional Collaboration
- Work closely with R&D, Systems, UX, Clinical, and Verification teams to embed usability throughout design controls.
- Communicate usability findings and recommendations to stakeholders, influencing design decisions and risk mitigations.
- Participate in requirement reviews and ensure usability considerations are reflected in requirements and design.
Continuous Improvement
- Analyze post‑market feedback and field insights to identify usability problems and propose design improvements.
- Provide usability training, coaching, and best‑practice guidance within project teams.
Required Skills & Experience
- Bachelor’s or Master’s degree in Human Factors Engineering, HCI, Cognitive Science, Industrial Design, Biomedical Engineering, or related field.
- 5+ years of experience in usability engineering, usability testing, UX, or human‑centered design, preferably in medical devices or healthcare technology.
- Strong knowledge of usability standards and regulatory guidance including IEC 62366‑1, FDA Human Factors Guidance, and HE75.
- Experience planning, executing, and documenting usability studies in regulated environments.
- Ability to conduct task analysis, workflow evaluations, and contextual research in clinical environments.
- Experience working with complex medical systems involving hardware, software, and integrated workflows.
- Excellent communication, cross‑functional collaboration, and documentation skills.
- Ability to work independently, drive usability activities, and influence stakeholders.
Behavioral Competencies
- Strong user advocacy and patient‑safety mindset.
- Analytical and systems‑thinking approach.
- Ability to challenge design decisions constructively and improve design quality.
- Adaptability and ability to work independently in complex development environments.
Experience Level
5+ years (mid‑senior level usability engineer)
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