Functieomschrijving
Job description As a consultant, you will be embedded in a high‑tech innovation environment, leading usability engineering and design validation activities for medical devices, from user research and risk analysis through product release and post-market follow-up. You will help multidisciplinary teams understand user needs, shape safe and user-centered interfaces, and generate the evidence required for regulatory approval and product quality. You will work across the full product lifecycle, partnering with design, engineering, quality, regulatory, clinical marketing, and project management teams. Responsibilities
- Deliver usability requirements, plans, and evidence throughout the medical device design and development process.
- Conduct workflow analysis, user research, task analysis, and context-of-use assessments to identify user needs and usability requirements.
- Analyze post-market data, identify usability issues, and lead Usability FMEA activities.
- Define usability engineering plans and coordinate activities with project managers, clinical marketing, designers, engineers, and other business partners.
- Plan and execute formative and summative usability evaluations, document findings, and follow up on design actions.
- Advise design teams on usability implications of product changes and support the development of safe, user-centered UI and UX solutions.
- Lead design validation activities by defining the validation strategy, preparing plans and protocols, executing evaluations, and documenting results.
- Apply medical device usability and human factors requirements throughout the product lifecycle, while maintaining effective collaboration across subject areas and international teams.
- Master’s degree or PhD in human factors engineering, human-computer interaction, cognitive science, product design, interaction design, or a related field.
- 2 to 3 years of experience in usability engineering for medical devices, covering user needs, early design activities, validation, and post-market follow-up.
- Practical experience conducting workflow analysis, task analysis, user research, usability evaluations, and formal usability reporting.
- Experience providing clear input to UI and UX designers, risk managers, engineers, quality teams, and regulatory stakeholders.
- Experience defining design validation strategies, creating validation plans and protocols, executing validation activities, and documenting conclusions.
- Strong 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.
- Familiarity with structured product development, risk management, document control, and project management processes.
- Ability to work independently, raise concerns clearly, advocate for user needs, and lead activities with limited supervision.
- Excellent communication, presentation, leadership, collaboration, and formal writing skills, with fluent written and spoken English and experience working with multidisciplinary teams across different countries.