About Aerogen:
Headquartered in the vibrant city of Galway, 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 eight-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 Design Assurance Engineer II will work with the R&D, Regulatory, Process Development, Clinical and Manufacturing Engineering functions and being primarily responsible for Medical Product Approval (MDR and FDA 510k), Design Assurance and Risk Management Activities

What are the key responsibilities?  
• Collaborate with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project team environment providing Technical and Quality expertise to the team.
• Provide both quality and technical input to the stage gate design reviews, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products.
• Review/analyse whether current products and processes comply with standards such as ISO 13485 & EU MDR etc.
• Have experience in risk management, validation techniques, statistical techniques, and compliance with FDA/MDR regulatory requirements. 
• Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
• Use opportunities in project assignments to develop self & other team members. 
• Give technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer, and Design Assurance Technician. 
• Build Quality into all aspects by maintaining compliance for all quality requirements. Participates in Aerogen external audits including notified body.
• Provide design quality support in the resolution of product assessments, complaints investigation, CAPAs, regulatory requirement changes.
• Methodical review approach and capable of initiating and leading change through continuous improvement.

What education and experience are required? 
• A degree in Engineering, Technology, or Science.
• Minimum 3-5+ years’ experience working in a regulated medical device or pharmaceutical company. 
• Training in product risk management, problem solving methods, reliability engineering, process validation, software validation, usability or biocompatibility would be advantageous.

What key skills will make you great at the role? 
• Excellent planning, coordination and communication skills.
• Attention to detail
• Understanding of ISO 14971 & 13485 and FDA QS regulations.
• Ability to work within a team environment to achieve agreed company goals.
• Ability to communicate quality / regulatory concepts effectively.
• Understanding of Quality Systems and Design Control Process.
• Proficiency in use of desktop software applications such as MS office, Word, Excel, PowerPoint.
• Experience in risk management, validation techniques, statistical techniques, and compliance with FDA/MDR regulatory requirements. 
• Some travel may be required with the role.

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. There’s something for everyone! Here is an idea of what we offer: 
  • Excellent medical care. 
  • Bonus & Pension. 
  • ‘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 

Check out our careers website to discover more about Life at Aerogen 

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 careers@aerogen.com. Please include your name and preferred method of contact.