Manufacturing Engineer

The Udder Group; Shannon; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Excellent medical care

Aerogen Connect

Charitable giving

Job summary

Aerogen, Galway-based leader in acute care aerosol drug delivery, seeks an experienced engineer to support design verification and process validation in medical device manufacturing. You will help solve complex quality issues, analyze data, plan projects, and ensure compliance with EN ISO 13485, EU‑MDR, MDSAP and FDA requirements, including travel to vendor sites up to 10%.

Join a global team committed to delivering better patient outcomes, with strong collaboration, leadership opportunities and

Qualifications

• Level 8 qualification in Engineering, Technology or Science.
• A minimum of 3 years’ relevant experience.
• Knowledge of EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements.

Skills

Design verification

Process validation

Root cause analysis

Data analysis

Project planning

Organisational skills

Leadership

Regulatory knowledge

MS Office

Travel readiness

Education

Level 8 qualification in Engineering/Tech/Science

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 55 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.

Job Description

What is the role?

- add text

Qualifications

What education and experience are required?

• Level 8 qualification in Engineering, Technology or Science.
• A minimum of 3 years’ 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 with a strong attention to detail.
• 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.
• 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%).

Additional Information

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.

We welcome applications from all backgrounds.