Senior Human Factors & Usability Consultant

Benefits

Additional Information

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: - 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, 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. 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 (20%