Manufacturing Engineer II

Aerogen Ltd.; Galway; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Aerogen Ltd. in Galway is seeking a Manufacturing Engineer II to drive the delivery of product and process improvements across manufacturing teams.

You will lead cross-functional projects, develop and validate processes, and support QA, sustainability, and supplier changes, with a focus on data analysis, problem solving and continuous improvement in a medical device environment. Expect travel up to 10% to vendor sites and manufacturing sites as required.

Qualifications

• Knowledge of design verification and process validation frameworks.
• Strong problem-solving capability with root cause analysis.
• Data analysis and reporting with attention to detail.
• Project planning and delivery with risk management.
• Experience in medical device manufacturing and compliance with EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements.

Responsibilities

• Work within cross-functional teams to introduce new manufacturing processes.
• Lead and contribute to cross-functional quality, sustainability, vendor change and cost improvement projects from initiation to delivery.
• Execute and support process and equipment development and validations including DV, IQ, OQ, PQ, PPQ, TMV with protocol development and data analysis.
• Support operational readiness activities including manufacturing documentation, PFMECA, and BOM creation.
• Collaborate with R&D, operations, quality, sales and marketing through the product and process development lifecycle.
• Travel to manufacturing and vendor sites to support service and project activities (up to 10%).

Skills

Design verification

Process validation

Root cause analysis

Data analysis

Project planning

Organization

Collaboration

Leadership

Regulatory standards

MS Office

Travel readiness

Education

Level 8 qualification in Engineering, Technology or Science

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, 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 II is responsible for working collaboratively across the business to drive the delivery of product, process and sustainability improvement projects. This role offers the exciting opportunity to identify and implement creative and innovative solutions using data analytics, problem solving and influencing capabilities.

What are the key responsibilities?
• Work within cross-functional team environments to introduce new manufacturing processes.
• Lead and contribute to cross-functional, Quality, Sustainability, Vendor change, and Cost Improvement projects from initiation and feasibility to final delivery.
• Execute and support process and equipment development and validations including DV, IQ, OQ, PQ, PPQ, TMV. This will include protocol development, testing, data analysis, report generation.
• Support operational readiness activities including manufacturing documentation, PFMECA, and BOM creation.
• Support project scoping, planning and approval with due regard to objectives, need, costs, risks, schedule, and resource management.
• Work with external vendors to collaborate and support improving Aerogen processes and manufacturing capabilities.
• Lead and contribute to troubleshooting activities for issues with a cross-functional team in continuous improvement and sustaining activities.
• Collaborate with and communicate effectively to the R&D, operations, quality, sales, and marketing functions through the product and process development lifecycle.
• Perform other assigned tasks as directed by Supervisor or Head of Function.

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.
• 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 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.
• 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 [e-mail]. Please include your name and preferred method of contact.

Product approvals and set ups may vary by country. Always refer to the user instructions suppliedwith the product for full set up instructions, warnings, cautions andcontraindications.