Human Factors Engineer

Aerogen; Galway; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Excellent medical care

Aerogen Connect

Job summary

Aerogen, a Galway-based leader in acute care aerosol drug delivery, seeks a Human Factors Engineer/Usability Engineer to drive usability studies and regulatory submissions across hospital, home, and EMS settings.

You will coordinate formative and summative studies, develop Usability Engineering Files, and work with Design Assurance and Regulatory teams to improve devices, packaging, and labeling.

Qualifications

• Experience in usability engineering for medical devices.
• Strong knowledge of human factors standards and risk analysis.

Responsibilities

• Coordinate formative and summative usability studies in hospital/home/EMS settings.
• Prepare Usability Engineering File documentation (DIRs, UIEPs, UOUPs, Task Analysis).
• Generate HFE/UE reports for regulatory submissions (EU/US).
• Support MDR projects with human factors input.
• Develop and evaluate instructions for use to reduce use errors.
• Work with cross-functional teams to improve design and labeling.

Skills

Usability engineering

IEC 62366-1

Project management

Communication

Education

Engineering/Science 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 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?

• Working 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 support Design Assurance and Regulatory teams in relation to human factors and usability engineering activities.
• Support human factors and 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.
• Contribute to the generation and compilation of Usability Engineering File documentation, including project DIRs (Design Input Requirement Documents), Usability Sections, UIEPs, UOUPs and Task Analysis documents.
• Generate HFE/UE reports and support regulatory submissions in Europe and the US.
• Support MDR project teams by providing human factors and usability engineering input.
• 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 of 3-5 years' experience working in the 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?

• Good 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.
• 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 as part of a team.

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. If you have any difficulty using our application process, please contact us by emailing [e-mail]. Please include your name and preferred method of contact.