1 месяц назад
Senior Human Factor / Usability Consultant (F/M/X)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Human Factor / Usability Consultant (F/M/X) (medical devices): Leading usability engineering and design validation across the medical device lifecycle with an accent on user research, risk analysis, regulatory evidence, and safe user-centered interfaces. Focus on planning and executing formative and summative evaluations, conducting Usability FMEA, and documenting validation results for product release and post-market follow-up.
Location: Netherlands
Company
is an independent technology consulting firm delivering technology and engineering solutions across Information Systems & Digital, Telecom, Life Sciences, and Engineering.
What you will do
- Lead usability engineering and design validation activities for medical devices across the full product lifecycle.
- Conduct workflow analysis, user research, task analysis, and context-of-use assessments to define user needs and usability requirements.
- Plan and execute formative and summative usability evaluations, document findings, and track design actions.
- Analyze post-market data, identify usability issues, and lead Usability FMEA activities.
- Define validation strategies, plans, and protocols; execute evaluations and document conclusions for regulatory and quality evidence.
- Collaborate with design, engineering, quality, regulatory, clinical marketing, and project management teams.
Requirements
- Master’s degree or PhD in human factors engineering, human-computer interaction, cognitive science, product design, interaction design, or a related field.
- 2–3 years of usability engineering experience for medical devices, including user needs, early design, validation, and post-market follow-up.
- Practical experience with workflow analysis, task analysis, user research, usability evaluations, and formal reporting.
- Knowledge of medical device regulations and standards, including IEC 62366-1, FDA human factors guidance, NMPA guidelines, FDA 21 CFR 820.30, EU MDR, ISO 13485, and ISO 14971.
- Expertise in human factors, interaction design, usability methods, cognitive ergonomics, and physical ergonomics.
- Fluent written and spoken English, with strong communication, presentation, leadership, collaboration, and formal writing skills.
Culture & Benefits
- Work in a high-tech innovation environment with multidisciplinary and international teams.
- Collaborate with colleagues across more than 60 countries and five continents.
- Contribute to an inclusive and equal-opportunity workplace.
- Receive feedback throughout a structured recruitment experience.
Hiring process
- Brief virtual or phone call.
- Approximately three interviews, depending on seniority.
- Potential case study, technical assessment, role play, or problem-solving exercise.
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