Senior Human Factors Engineer/ Usability Engineer (HFE/UE)
Senior Human Factors Engineer/ Usability Engineer (HFE/UE)
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Job Description
About Aerogen:
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 and ten-time winner of the Zenith award for Respiratory Care Excellence in North America collectively our employees make a difference to patients lives every day having already reached 20 million patients in over 80 countries.
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 finding innovative solutions to even the most complex problems all in the name of delivering better patient care.
Our business is growing 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. Join us as we continue to #discoverbetter.
What is the role
The Senior HFE/UE will join Aerogens 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.
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.
Conduct formative and summative usability studies across hospital home and EMS environments.
Generate HFE/UE 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.
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 patient lives and our ethos is to #discoverbetter. 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. Theres something for everyone! Here is an idea of what we offer:
Competitive bonus plan.
Above market life insurance.
Opportunities for development and professional growth.
Aerogen Connect our employee-led program that helps our global teams unite and have fun.
We donate 1% of profits and time to charities and organizations.
Visit our careers website for more information about life at Aerogen.
Required Experience:
Senior IC
Employment Type
Full Time
