Senior Human Factors Engineer

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

Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards, including being named Galway Chamber Company of the Year 2025, and twelve‑time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries.

Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work.

We lead the way by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes.

Our business continues to grow rapidly across the globe and, as we grow, our core culture of "We Care" universally connects us. We believe that your ambition and integrity fuels ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers.

What is the role?

The Senior Human Factors Engineer/Usability Engineer will join Aerogen’s R&D User Experience department and will be responsible for coordinating, conducting, analysing, reporting formative and summative human factors studies on Aerogen products in hospital, home and EMS environments.

What are the key responsibilities?

• Company Subject Matter Expert (SME) on IEC 62366-1; Application of Usability Engineering to Medical Devices.
• Working knowledge of HE75 Human Factors Engineering - Design of Medical Devices
• Working knowledge of FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices.
• Working knowledge of ISO14971, with the ability to provide subject-matter expertise to Design Assurance and Regulatory teams.
• Support usability engineering activities across multiple projects, working with cross functional project teams to improve the design of Aerogen products, packaging, labelling, and instructions for use in order to reduce the potential for use errors.
• Design, organise and conduct formative and summative usability studies across hospital, home and EMS environments.
• Generate and provide usability subject‑matter expertise and generate and compile Usability Engineering File documentation - including project DIRs (Design Input Requirement Document) Usability Sections, UIEPs, UOUPs, and Task Analysis documents.
• Generate Human Factors Engineer/Usability Engineer reports and files for regulatory submissions in Europe and US.
• Key member of MDR project teams.
• Design and develop instructions for use and evaluate how instructions for use can be improved.
• Work in compliance with medical device industry best practices.

What education and experience are required?

• Qualification in Engineering, Technology, Science, Psychology, Human Factors Engineering, User Experience, Product design or similar with a minimum 6 years’ experience working in medical device industry.
• Experience with various user research methodologies such as ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, device user interface evaluation, task analysis, hazard analysis, use‑related risk analysis, formative and summative studies.

What key skills will make you great at the role?

• In depth knowledge of IEC 62366-1: Application of usability engineering to medical devices.
• Working knowledge of HE75 Human Factors Engineering - Design of Medical Devices
• Working knowledge of FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices.
• Working knowledge of ISO14971, with the ability to provide subject‑matter expertise to Design Assurance and Regulatory teams.
• Very strong organisational, Project Management and communication skills.
• Empathy and good people skills are required for this role.
• Meticulous attention to detail.
• Flexibility to travel to conduct studies.
• Must be capable of both working independently and in a group.

What is it like to work at Aerogen?

Our purpose is to transform patients’ lives and innovation is embedded in our culture. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non‑financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:

• Excellent medical care.
• ‘Aerogen Connect’ - our employee led programme which supports our global teams to unite and have fun.
• We pledge 1% of profits and time to charities and organisations.

Aerogen is committed to promoting diversity, inclusion and equality in the workplace.