Senior Usability Engineer, Medical Devices & Human Factors

Wallace Myers International; Galway; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Flexible working arrangements

Collaborative team

Job summary

Wallace Myers International in Galway is seeking a Senior Usability/Human Factors Engineer to lead patient- and user-focused usability activities from concept through validation. You will collaborate with R&D, clinical and QA teams to ensure safe, intuitive and effective medical devices.

The role requires at least 3 years in usability engineering within regulated healthcare, strong IEC 62366-1 and ISO 14971 knowledge, and hands-on study experience.

Qualifications

• Qualification in Human Factors, Usability Engineering, Biomedical Engineering, Psychology, Ergonomics, Product Design or related field.
• At least 3 years of usability engineering experience, including medical devices or other regulated healthcare products.
• Hands-on experience planning, conducting, analysing and documenting usability studies.
• Knowledge of IEC 62366-1 and ISO 14971 risk management.
• Experience producing study protocols/reports and regulatory documentation.
• Strong communication and cross-functional collaboration skills.
• Summative usability validation studies and FDA/Human Factors guidance for submissions.

Responsibilities

• Plan and coordinate usability engineering activities, plans, deliverables and milestones.
• Define users, environments and interactions; conduct interviews and workflow assessments.
• Translate research into user needs, inputs, requirements and recommendations.
• Identify use errors and hazardous scenarios; support risk assessments and risk reduction.
• Plan, conduct and analyse formative and summative usability studies and validation.
• Evaluate device controls, displays, packaging, labeling and training materials.
• Maintain Usability Engineering File and contribute to DHF documentation and design reviews.
• Coordinate with R&D, RA/QA, clinical and external providers to deliver studies on schedule.

Skills

Usability Engineering

Human Factors

Medical Devices

Regulatory Knowledge

Education

Human Factors / Usability Engineering degree

Job description

Wallace Myers International in Galway is seeking a Senior Usability/Human Factors Engineer to lead patient- and user-focused usability activities from concept through validation. You will collaborate with R&D, clinical and QA teams to ensure safe, intuitive and effective medical devices.

The role requires at least 3 years in usability engineering within regulated healthcare, strong IEC 62366-1 and ISO 14971 knowledge, and hands-on study experience.