Vendor Engineer II

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

Benefits offered by this job

Excellent medical care

Bonus & Pension

Aerogen Connect – employee programme

Job summary

Aerogen, headquartered in Galway, Ireland, is seeking a Vendor Engineer to drive technical and quality activities with external suppliers. You will partner with cross-functional teams to onboard suppliers, define CPPs/CTQ targets, and lead qualification activities from IQ to PQ to ensure supplier capability meets Aerogen’s requirements.

You will collaborate with Operations and Supply Chain to optimize processes, support new product introductions, and deliver continuous improvements while

Qualifications

• At least 4 years’ equivalent experience in Engineering, Process Development or Manufacturing Environment.
• Minimum of a primary degree in Engineering or related technical field.

Responsibilities

• Technical member within cross-functional teams responsible for supplier management activities (Vendor Onboarding, Process Changes and Quality Performance).
• Partner with Supply Chain to determine technical capability and suitability of potential new suppliers.
• Identify Critical Process Parameters (CPPs) and appropriate controls to achieve component CTQ characteristics.
• Collaborate with Operations and internal stakeholders to facilitate supplier onboarding and supplier changes.
• Manage and lead all equipment, process, performance, and test method validation activities including IQ, OQ and PQ, with existing and new Suppliers.
• Lead Vendor Engineering support at Aerogen on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements and New Product Introductions etc.

Skills

Communication skills

Six Sigma Green/Black Belt

Quality engineering

Supplier management

Team collaboration

Education

Primary degree in Engineering or related technical field

Tools

Gauge R&R

Injection moulding

ISO 13485 / FDA QSR

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 Vendor Engineer is responsible for providing technical and quality engineering activities of external suppliers, ensuring that suppliers are capable of consistently delivering products, materials, and services that meet Aerogen’s requirements. The role partners with cross-functional teams to drive effective supplier onboarding and supplier changes, support new product and program introductions, lead technical problem-solving, and deliver ongoing improvements in supplier capability and performance.

What are the key responsibilities?

• Technical member within cross-functional teams responsible for supplier management activities (Vendor Onboarding, Process Changes and Quality Performance).
• Partner with Supply Chain to determine technical capability and suitability of potential new suppliers.
• Identify Critical Process Parameters (CPPs) and appropriate controls to achieve component Critical to Quality (CTQ) characteristics.
• Collaborate with Operations and internal stakeholders to facilitate supplier onboarding and supplier changes.
• Manage and lead all equipment, process, performance, and test method validation activities including IQ, OQ and PQ, with existing and new Suppliers.
• Lead Vendor Engineering support at Aerogen on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements and New Product Introductions etc.
• Collaborate with cross functional internal teams to establish inspection plans, frequencies, and test methods for incoming material/parts.
• Partner with suppliers to monitor key process outputs and performance metrics, using data analysis to identify trends, mitigate risks, and implement sustainable process improvements.
• Champion continuous process improvement and, in conjunction with other functions, identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
• Partner with Supply Chain, including Procurement and Production Planning, to ensure sufficient validated supplier capacity is available to support demand for externally manufactured components.
• Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.
• Maintain compliance with ISO and FDA Quality System regulations.
• The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary. The role will require a high degree of flexibility to coordinate the variety of tasks.

What education and experience are required?

• At least 4 years’ equivalent experience in Engineering, Process Development or Manufacturing Environment.
• Minimum of a primary degree in Engineering or related technical field.

What key skills will make you great at the role?

• Ability to work on own initiative.
• Strong team member with the ability to identify and drive implementation of innovative quality improvements (Six Sigma Green / Black Belt Certification an advantage).
• Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are addressed appropriately.
• Demonstrate and actively promote high levels of professional quality engineering.
• Good communication skills. Must have the ability to communicate effectively at all levels of the company and with suppliers.
• Demonstrated knowledge and experience of leading and executing equipment, process and performance qualification.
• Demonstrated knowledge and experience of leading and executing measurement system analysis, including Gauge R&R.
• Working knowledge of thermoplastics Injection Moulding and Silicone Moulding.
• Good administrative/organizational ability with high level of attention to detail.
• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
• Thorough understanding of ISO 13485 and FDA QSR standards.

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.