Manufacturing Engineer I

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 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 Manufacturing Engineer I is responsible for collaborating with Aerogens R&D and Commercial teams to deliver on strategic growth plans through the advancement of the current and future Product technologies. The role will support the initial Design stage gates while taking the lead to deliver the final stage all cases the role is expected to challenge and improve NPD Manufacturing systems as enablers to advance project execution.

What are the key responsibilities
Lead NPD Manufacturing project tasks from product initial concept to Release to Sales to deliver Patient focused Product enhancements.
Early design stage involvement will include working with R&D and supply chain on supplier selection and qualification plans.
Completing product and process changes through process characterization process validation change control and documentation updates.
Later design stage involvement will collaborate with Regulatory Commercial and Production to prepare for regional registration and release to sales with the creation of BOMs labels and Manufacturing documentation.
Troubleshooting with cross functional teams including Quality Engineering Supply Chain Manufacturing and R&D.
Identification of improvement opportunities through design stage gate review activities.
Evaluate proposed changes to equipment / processes / components in relation to the impact on product quality safety stability performance or waste technology.
Support the design development and testing of Aerogen packaging solutions.
Perform other assigned tasks as directed by Supervisor or Head of Function.

What education and experience are required
A minimum of Level 8 degree in a relevant STEM discipline
4 years of relevant experience

What key skills will make you great at the role
Technical Experience: Knowledge of design verification and process validation frameworks with focus on equipment / manufacturing processes.
Strong Problem-Solving capability: Knowledge and experience of root cause analysis techniques and the application of problem-solving methodologies in the development assessment and implementation of potential solutions to existing or potential engineering and quality issues.
Data analysis: Generates and analyses data and presents findings in a logical actionable way.
Project Planning: Executes and manages project deliverables by planning monitoring adjusting and communicating project activities to ensure that project deliverables timelines risks and budgets are met including developing contingency and risk mitigation plans.
Organisation: Strong organizational skills with a meticulous attention to detail.
Collaboration: Effective communication and interpersonal skills; written verbal and presentation.
Leadership: Excellent leadership skills with demonstrated decision-making ability.
Experience working in medical device manufacturing and in maintaining and improving processes with a good understanding of EN ISO 13485:2016 EU MDR MDSAP and FDA requirements as these apply to this role.
Highly motivated self-starter able to work in a dynamic environment with little supervision or daily direction.
Proficiency in Microsoft Office software.
Flexibility to travel to manufacturing and vendor sites to support service and project activities. Some national and international travel will be required with role (up to 10%).

What is it like to work at Aerogen
Our purpose is to transform patients lives and innovation is embedded in our 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:
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.
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 emailprotected. Please include your name and preferred method of contact.