Senior Medical Device Usability Engineer

AMARIS GROUP SA; Netherlands; On-site; EUR 75,000 - 95,000; Full time

Job summary

Amaris Group SA in the Netherlands seeks a Senior Human Factor / Usability Consultant to lead usability engineering and design validation for medical devices, from user research to post‑market follow‑up.

You will collaborate with multidisciplinary teams across design, engineering, quality, regulatory, clinical marketing, and project management to ensure user‑centered interfaces and regulatory compliance, delivering evidence for approval and product quality.

Qualifications

• Master’s degree or PhD in human factors, HCI, or related field.
• 2–3 years of usability engineering experience for medical devices.
• Experience in workflow analysis, task analysis, user research, and usability evaluations.
• Ability to coordinate with cross-functional teams including design, engineering, regulatory.
• Strong knowledge of IEC 62366-1, FDA guidance, EU MDR, ISO 13485, and ISO 14971.

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.

Skills

Usability engineering

Workflow analysis

User research

Regulatory knowledge

English communication

Education

Master’s degree or PhD in Human Factors / HCI

Job description

Amaris Group SA in the Netherlands seeks a Senior Human Factor / Usability Consultant to lead usability engineering and design validation for medical devices, from user research to post‑market follow‑up.

You will collaborate with multidisciplinary teams across design, engineering, quality, regulatory, clinical marketing, and project management to ensure user‑centered interfaces and regulatory compliance, delivering evidence for approval and product quality.