Quality Engineer II (Metrology)

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

Benefits offered by this job

Excellent medical care

Bonus & Pension

Aerogen Connect

Job summary

Aerogen Ltd. in Galway seeks a Metrology Engineer II to develop, maintain, and improve measurement systems used in manufacturing and product development.

You will ensure components meet specifications and regulatory standards, collaborating with Manufacturing, R&D, and suppliers to support validation and continuous improvement. The role requires minimum 3 years in medical device or pharma, knowledge of ISO 13485, EU-MDR, MDSAP, and experience with CMMs, Smartscope, and statistical tools such as

Qualifications

• Minimum STEM qualification at Level 8 or higher.
• Minimum 3 years’ experience in medical device or pharma sectors.
• Experience introducing measurement systems and metrology processes.
• Familiarity with EN ISO 13485:2016, EU-MDR, MDSAP, FDA regulations.

Responsibilities

• Develop and implement dimensional inspection methods.
• Operate metrology equipment (CMMs, Optical comparators, Vision systems).
• Create and maintain inspection plans and validation activities (IQ/OQ/PQ).
• Support quality investigations, CAPAs and root cause analyses.
• Collaborate with engineering and production to meet regulatory requirements.

Skills

Metrology implementation

Root cause analysis

QA compliance

Problem solving

Cross-functional collaboration

Data analysis (Minitab)

Education

STEM qualification (Level 8+)

Tools

Smartscope

Keyence

CMM programming

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 Metrology Engineer is responsible for developing, maintaining, and improving measurement systems and dimensional inspection methods used in manufacturing and product development. This role ensures that products, components, and processes meet defined specifications, regulatory standards, and customer requirements through accurate and reliable measurement techniques.

The Metrology Engineer works closely with Manufacturing, R&D, and suppliers to support process validation, root cause analysis, equipment qualification, and continuous improvement initiatives.

Key Responsibilities

New Method / Equipment Introduction

• Develop and implement dimensional inspection and measurement methods.
• Operate and program metrology equipment such as:
• CMMs (Coordinate Measuring Machines)
• Optical comparators, Smartscope, Laser scanners, Vision systems, Micrometers, calipers, gauges, and precision instruments
• Create and maintain inspection plans.
• Complete validation and qualification activities (IQ/OQ/PQ where applicable) and Test Method Validation.
• Conduct Measurement System Analysis (MSA), Gauge R&R, and capability studies.

Continuous Improvement

• Support quality investigations, CAPAs, non-conformance analysis, and root cause investigations.
• Support analysis of performance to reduce variation and improve accuracy.
• Provide day-to-day technical support for production metrology systems.
• Introduce improved methods or technologies.
• Trending and reporting of internal manufacturing performance.
• Align data management tools and develop automated inspection and reporting solutions where possible.

Cross Functional Support

• Collaborate with engineering and production.
• Support NPI and customer/regulatory requirements.
• Engage with Supplier Quality to align on methods between Aerogen manufacturing and Supplier processes.
• Maintain compliance with ISO and FDA Quality System regulations.
• Assist with completion of relevant NC/CAPA actions and ownership as identified.

Education and Experience

• Minimum level 8 or higher STEM Qualification.
• Minimum of three years’ experience gained within the medical device or pharma sectors.
• Experience in introduction of measurement systems.

Key Skills

• Technical Experience: Technical expertise in metrology implementation. Prior experience of Smartscope, Keyence and CMM programming software would be advantage.
• Problem Solving: Apply structured problem‑solving methodologies to support investigations, contribute to root cause analysis, and help identify practical and effective solutions.
• Results Focused: Deliver assigned objectives and tasks in a timely manner while working towards clear, outcome‑focused goals that support team and business priorities.
• Accountability: Take ownership of assigned work, follow through on deliverables, and proactively communicate progress or issues as they arise.
• Collaboration: Work effectively with cross‑functional teams, communicating clearly and professionally to support problem resolution and project success.
• Regulatory & Quality Awareness: Apply a working knowledge of medical device manufacturing and relevant standards and regulations (EN ISO 13485:2016, EU-MDR, MDSAP, FDA) to support compliant processes and quality outcomes.
• Self‑Management: Operate as a motivated self‑starter capable of managing responsibilities in a dynamic environment while seeking guidance when appropriate.
• Technical Tools: Utilize Microsoft Office and statistical tools such as Minitab to analyse data and support process monitoring and improvement activities.

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.

Job Title
Quality Engineer II (Metrology)

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.