Medical Device Usability Engineer — Impact Patient Safety

Trinamics; Breda; Vor Ort; EUR 50.000 - 67.000; Vollzeit

Benefits dieser Stelle

Permanent secondment to leading health

Extensive benefits package

Zusammenfassung

Trinamics in Breda, Netherlands, seeks a Usability Engineer to analyze workflows, conduct user research, and define user needs for medical devices. You will craft usability plans and coordinate activities with project managers and clinical partners to ensure compliant designs.

You will plan and run usability evaluations, lead Usability FMEA, and analyze post-market data to resolve usability issues. The role requires strong English skills and deep knowledge of IEC 62366-1, FDA Human Factors, and

Qualifikationen

• At least 3 years of usability engineering experience.
• Hands-on task analysis and usability evaluation reporting.
• Excellent written and spoken English.

Aufgaben

• Perform workflow analysis and user research to define user needs and usability requirements.
• Write usability engineering plans and coordinate usability activities with project managers and partners.
• Plan and run usability evaluations and ensure critical findings are resolved in design.
• Lead Usability FMEA and analyze post-market data for usability issues.
• Advise design team on usability impact of changes and support user-centred UI/UX solutions.
• Deliver usability evidence for product releases meeting regulatory, customer and business needs.
• Ensure usability engineering complies with IEC 62366-1, FDA Human Factors guidance and NMPA guidelines.
• Maintain good cooperation with other disciplines within the organisation.

Kenntnisse

Usability engineering

Task analysis

Usability evaluations

Regulatory awareness

English proficiency

Ausbildung

Master's degree

Jobbeschreibung

Trinamics in Breda, Netherlands, seeks a Usability Engineer to analyze workflows, conduct user research, and define user needs for medical devices. You will craft usability plans and coordinate activities with project managers and clinical partners to ensure compliant designs.

You will plan and run usability evaluations, lead Usability FMEA, and analyze post-market data to resolve usability issues. The role requires strong English skills and deep knowledge of IEC 62366-1, FDA Human Factors, and