Senior Human Factors & Usability Consultant

Job Description

Lead and manage end‑to‑end human factors and usability programs for client medical products, from planning through execution, analysis, and regulatory‑grade reporting.

• Develop and own the Master Usability Plan (MUP) and all associated protocols, study materials, and deliverables in alignment with IEC 62366, ISO 14971, ISO 9241, FDA Human Factors Guidance (2016), and other applicable standards.
• Define participant profiles, task flows, success criteria, and user‑related risk analyses to support both formative and summative (validation) usability evaluations.
• Lead and moderate onsite and remote usability testing, ensuring high‑quality data capture, robust task analysis, and thorough root‑cause analysis of observed use issues.
• Analyze qualitative and quantitative usability data to produce submission‑ready reports with clear design recommendations, risk mitigations, and traceability to regulatory expectations.
• Collaborate closely with client engineering, quality, and regulatory teams to support the development and maintenance of Use‑Related Risk Analyses (URRA), where applicable.
• Provide human factors and usability input to Health Economics and Outcome Research (HEOR) related activities, supporting study design, endpoint selection, and interpretation of user‑ and workflow‑related outcomes.
• Ensure all usability deliverables meet regulatory requirements, client quality standards, and internal SOPs.
• Communicate directly with clients and cross‑functional partners to align on study scope, findings, and next steps.
• Where regulatory interactions are required, support those discussions in collaboration with internal and/or client regulatory SMEs.
• Support pre‑award client meetings and communication, including proposal development by providing technical input on feasibility and timelines.
• Support development of regulatory strategy through collaboration with internal and/or client regulatory SMEs.
• Contribute to the development and refinement of internal best practices, templates, and SOPs to ensure consistent, audit‑ready deliverables.

Other duties as assigned.

• Bachelor’s or Master’s degree in Human Factors Engineering, HCI, Cognitive Psychology, Industrial Design, Biomedical Engineering, or a related field; or equivalent practical experience (3+ years).
• 3–5+ years of relevant human factors/usability experience in regulated industries (medical devices preferred).Demonstrated experience developing protocols and materials and moderating formative usability studies (remote and/or onsite).
• Working knowledge of FDA Human Factors Guidance, IEC 62366‑1, ISO 9241, and familiarity with ISO 14971 concepts and documentation interfaces.
• Strong analytical skills with ability to translate observations into clearly documented findings and recommendations.
• Strong technical writing skills and ability to produce high‑quality draft deliverables for senior review.
• Effective stakeholder management and communication skills; able to work independently and elevate appropriately.

• Physical demands include regular talking or hearing, standing, walking, sitting, use of hands to finger, handle, or feel and reach with hands and arms, and occasional lifting of up to 25 pounds (12 kg).
• Frequent use of telephone and video conferencing tools and extensive use of computer keyboard and mouse; prolonged periods of sitting.
• Noise level in the work environment is usually moderate.
• Occasional travel required (20% - 35%).
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Minimum: $83,500.00
Target: $
Frequency:
Annual

Individual base pay depends on various factors, including primary work location, role complexity and responsibility, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company.