Human Factors & Useability Specialist

NAMSA•Minneapolis, MN

About The Position

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Execute end‑to-end human factors and usability activities for assigned projects, from study preparation through analysis and draft reporting, with oversight from senior staff. • Develop study protocols and materials for formative usability studies (task scenarios, success criteria, moderator guides, data capture tools) aligned with IEC 62366‑1, ISO 9241, and internal SOPs. • Support development and maintenance of project‑level plans and documentation (including inputs to Master Usability Plans and associated deliverables) as directed. • Define and document participant profiles, task flows, and success criteria in collaboration with project teams and clients. • Lead moderation of remote and onsite formative usability sessions; ensure high‑quality data capture and consistent facilitation. • Perform qualitative and quantitative analysis of usability data, including identification and clear articulation of observed use issues, patterns, and contributing factors. • Draft regulatory‑aligned usability reports with clear findings and actionable recommendations; maintain traceability to tasks, outcomes, and user-related risks. • Support use‑related risk management activities by contributing to URRA updates and aligning usability outputs with ISO 14971 risk documentation. • Communicate proactively with clients and internal partners regarding study scope, timelines, execution readiness, and preliminary observations (as appropriate). • Support proposal development by providing technical input on feasibility, timelines, and study approach; contribute to internal best practices and template refinement. • Other duties as assigned. Qualifications & Technical Competencies: • 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+ • 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 escalate appropriately. Working Conditions: • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kgs). • Frequent use of telephone and video conferencing tools. Extensive use of computer keyboard and mouse; prolonged periods of sitting. • Noise level in the work environment is usually moderate. • Occasional Travel required (10% - 25%) • If there is any discrepancy between the above and federal and local legal requirements, the legal requirements apply. Pay Range Minimum: $68,800.00 Pay Range Target: $98,000.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. NAMSA was founded on the principals of delivering quality customer service, conducting ourselves with integrity, respect for one another, open communication and collaboration. Whether you have a background in Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering, or Sales & Business, NAMSA offers exciting opportunities to align with your expertise.

Requirements

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+
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 escalate appropriately.

Responsibilities

Execute end‑to-end human factors and usability activities for assigned projects, from study preparation through analysis and draft reporting, with oversight from senior staff.
Develop study protocols and materials for formative usability studies (task scenarios, success criteria, moderator guides, data capture tools) aligned with IEC 62366‑1, ISO 9241, and internal SOPs.
Support development and maintenance of project‑level plans and documentation (including inputs to Master Usability Plans and associated deliverables) as directed.
Define and document participant profiles, task flows, and success criteria in collaboration with project teams and clients.
Lead moderation of remote and onsite formative usability sessions; ensure high‑quality data capture and consistent facilitation.
Perform qualitative and quantitative analysis of usability data, including identification and clear articulation of observed use issues, patterns, and contributing factors.
Draft regulatory‑aligned usability reports with clear findings and actionable recommendations; maintain traceability to tasks, outcomes, and user-related risks.
Support use‑related risk management activities by contributing to URRA updates and aligning usability outputs with ISO 14971 risk documentation.
Communicate proactively with clients and internal partners regarding study scope, timelines, execution readiness, and preliminary observations (as appropriate).
Support proposal development by providing technical input on feasibility, timelines, and study approach; contribute to internal best practices and template refinement.
Other duties as assigned.