Senior Usability/Human Factors Engineer

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

GALWAY | MEDICAL DEVICES
An exciting opportunity has arisen for a Senior Usability/Human Factors Engineer to join a growing medical device R&D team in Galway. You will lead patient- and user-focused usability activities from early concept development through to validation, ensuring products are safe, intuitive and effective. Working closely with R&D, clinical and quality/regulatory colleagues, you will turn user research and usability findings into practical design improvements.

Key Responsibilities

• Plan and coordinate usability engineering activities, including usability plans, deliverables and project milestones.
• Define intended users, use environments and user interactions; conduct interviews, observations and workflow assessments with relevant users.
• Translate research into user needs, design inputs, user-interface requirements, task analyses and actionable recommendations.
• Identify use errors, critical tasks and hazardous use scenarios; support use-related risk assessments and risk reduction measures.
• Plan, conduct and analyse formative usability studies and summative usability validation, including protocols, participant criteria, scenarios, data collection and reporting.
• Evaluate device controls, displays, accessories, packaging, labelling, instructions for use and training materials where applicable.
• Maintain the Usability Engineering File and contribute to Design History File documentation, design reviews and regulatory submissions.
• Coordinate with R&D, project management, RA/QA, clinical partners and external research providers to deliver studies on schedule.
• Relevant qualification in Human Factors, Usability Engineering, Biomedical Engineering, Psychology, Ergonomics, Product Design, HCI or related field, or equivalent practical experience.
• At least 3 years of relevant usability engineering, human factors or user-centred product development experience, including medical devices or another regulated healthcare product.
• Hands-on experience planning, conducting, analysing and documenting usability studies.
• Understanding of IEC 62366-1 and the relationship between usability engineering and ISO 14971 risk management.
• Experience producing formal study protocols/reports and controlled product development documentation.
• Strong communication, analytical and cross-functional collaboration skills.
• Summative usability validation studies and FDA human factors guidance for US or European submissions.
• Wearable or other patient-facing medical devices and research involving patients, caregivers or healthcare professionals.
• Physical user interfaces, device fit and comfort, cleaning and maintenance, and treatment workflows.
• Evaluation of instructions for use, packaging, labelling and training materials.

What's on Offer

A competitive salary and benefits package, flexible working arrangements and the opportunity to contribute to innovative medical device development within a collaborative, growing team.

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