Senior Human Factors Engineer - Medical Device Usability

Aerogen; Galway; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Excellent medical care

Aerogen Connect programme

Charitable contribution ethos

Job summary

Aerogen, headquartered in Galway, Ireland, is seeking a Senior Human Factors Engineer/Usability Engineer to join the R&D User Experience team. You will coordinate and conduct formative and summative usability studies for Aerogen medical devices across hospital, home and EMS environments.

In this role you will apply IEC 62366-1 and ISO14971 principles, work with cross-functional teams, and prepare usability documentation for regulatory submissions in Europe and the US.

Qualifications

• In-depth knowledge of usability engineering for medical devices.
• Experience applying IEC 62366-1 and ISO14971 in product teams.
• Familiarity with FDA guidance on usability engineering for medical devices.

Responsibilities

• Coordinate formative and summative usability studies across hospital, home and EMS environments.
• Generate usability reports and regulatory documentation.
• Provide SME support to regulatory and design teams to reduce use errors.
• Develop and evaluate instructions for use and improve user interfaces.

Skills

IEC 62366-1

HE75

FDA Guidance

ISO14971

Project Management

Empathy

Attention to detail

Education

Engineering/Science/UX degree

Job description

Aerogen, headquartered in Galway, Ireland, is seeking a Senior Human Factors Engineer/Usability Engineer to join the R&D User Experience team. You will coordinate and conduct formative and summative usability studies for Aerogen medical devices across hospital, home and EMS environments.

In this role you will apply IEC 62366-1 and ISO14971 principles, work with cross-functional teams, and prepare usability documentation for regulatory submissions in Europe and the US.