Usability Engineer

Usability Engineer & Validation Lead

• Eindhoven area
• € 5.000 - € 5.800

About the Role

We are looking for a Usability Engineer & Validation Lead to ensure that medical device products are intuitive, safe, and compliant throughout the entire product development lifecycle. In this role, you will lead usability engineering activities, define and execute design validation strategies, and collaborate with multidisciplinary teams to deliver high-quality, user-centred healthcare solutions that meet regulatory and business requirements.

Key Responsibilities

As a Usability Engineer & Validation Lead, you will:

• Drive usability engineering activities throughout the product development lifecycle, ensuring compliance with regulatory standards and user, customer, and business requirements.
• Conduct workflow analyses, user research, and context-of-use studies to identify user needs and define usability requirements.
• Analyse post-market data to identify usability-related issues and opportunities for product improvement.
• Lead Usability Failure Mode and Effects Analysis (uFMEA) activities.
• Develop usability engineering plans and coordinate usability activities with cross-functional stakeholders, including project management, clinical, marketing, engineering, and design teams.
• Plan, execute, and document formative and summative usability evaluations, ensuring findings are translated into design improvements.
• Provide expert guidance on usability implications of design changes.
• Ensure usability engineering practices comply with international regulations and standards, including IEC 62366, FDA Human Factors Guidance, and NMPA guidelines.
• Support the development of safe, intuitive, and user-centred UI and UX solutions.
• Define the overall product validation strategy and create validation plans, protocols, and reports.
• Execute design validation activities and ensure all validation objectives are achieved.
• Foster effective collaboration with multidisciplinary teams across a global organisation.

What You'll Bring

• A proactive, independent working style with a strong sense of ownership.
• Excellent communication, presentation, and stakeholder management skills.
• Confidence to advocate for user needs and influence design decisions.
• Strong collaboration skills when working with global, cross-functional teams.
• Ability to produce high-quality technical and regulatory documentation.
• Excellent written and spoken English.

Required Experience

• Minimum of 2–3 years of experience in usability engineering for medical devices, covering the complete development lifecycle from user research through usability validation and post-market evaluation.
• Hands-on experience conducting task analyses, usability evaluations, and translating user insights into product improvements.
• Experience collaborating with UI/UX designers, engineers, and risk management teams.
• Proven experience defining validation strategies, developing validation plans and protocols, and executing design validation activities.
• Solid understanding of medical device regulations and quality standards, including:
• IEC 62366-1
• FDA Human Factors Guidance
• FDA 21 CFR Part 820.30
• EU MDR
• ISO 13485
• ISO 14971
• NMPA requirements
• Strong expertise in Human Factors Engineering, interaction design, usability methodologies, cognitive ergonomics, and physical ergonomics.
• Demonstrated project management and cross-functional collaboration skills.
• Experience working within multidisciplinary and international development environments is considered an advantage.

Education

• Master's degree or PhD in Human Factors Engineering, Human-Computer Interaction (HCI), Cognitive Science, Product Design, Interaction Design, or another relevant discipline.