Usability Engineer, Best, Noord-Brabant

Location: Best, Noord-Brabant  |  Sector: Medical Devices  |  Start Date: 11/2/2026  |  Job ref: 59392

About the Company
An international organization operating in a highly regulated medical technology environment, focused on developing safe and reliable products for users worldwide.

Role Description
As a Usability Engineer, you will ensure that products are safe and intuitive to use throughout the design and development process. You will lead usability engineering and risk management activities, working closely with multidisciplinary teams to identify potential use-related risks, implement mitigations and demonstrate product safety in line with relevant regulatory requirements.

Key Responsibilities

  • Lead usability engineering activities throughout the product design and development lifecycle.
  • Conduct workflow analysis, user research and task analysis to identify user needs and define usability requirements.
  • Lead Usability FMEA and collaborate with Risk Management to identify, assess and mitigate potential risks.
  • Develop usability engineering plans and coordinate activities with project teams and relevant stakeholders.
  • Plan, conduct and document usability evaluations, ensuring critical findings are addressed.
  • Analyse post-market data and identify potential usability-related issues.
  • Advise design teams on usability aspects of product and design changes.
  • Support the development of user-centred interfaces and safe-to-use products.
  • Define and execute design validation strategies, plans and protocols.
  • Ensure compliance with relevant standards and regulations, including IEC 62366, FDA guidance and applicable medical device requirements.

Requirements
  • Master's degree or PhD in Human Factors Engineering, Human-Computer Interaction, Cognitive Science, Product or Interaction Design, or a related field.
  • At least 2–3 years of usability engineering experience within the medical device industry, covering activities from user needs and requirements through usability validation and post-market follow-up.
  • Practical experience with Usability FMEA, risk analysis and risk mitigation.
  • Experience conducting and reporting usability evaluations.
  • Experience with design validation, including strategy, plans, protocols and execution.
  • Strong understanding of relevant medical device regulations and standards, such as IEC 62366-1, FDA Human Factors Guidance, FDA 21 CFR 820.30, EU MDR, ISO 13485 and ISO 14971.
  • Knowledge of human factors, interaction design and cognitive and physical ergonomics.
  • Strong project management, coordination and stakeholder management skills.
  • Independent, proactive working style and the ability to collaborate across multidisciplinary teams.
  • Excellent written and spoken English.

59392

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Artemis Hadjidimitriou

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