Senior Manufacturing Engineer

Senior Process Development Engineer | Galway | Up to €75,000

We're looking for a hands-on process engineer who wants to be part of building something, not just maintaining it.

This is a strategic role at the heart of a growing medical device company in Oranmore, Galway. They're scaling fast, doubling in size year on year and they need someone who can own process development end to end, drive lean improvements on the floor, and help shape how the manufacturing operation grows over the next few years.

There's no large engineering team around you. You'll be the all-rounder who can write a URS in the morning, troubleshoot a process issue on the floor at lunchtime, and present findings to senior leadership in the afternoon. If that sounds like your kind of role, keep reading.

What you'll be doing:

• Designing, developing and validating robust manufacturing processes (IQ/OQ/PQ)
• Scaling production lines to meet significant year-on-year growth targets
• Driving continuous improvement using Lean methodologies — Kaizen, VSM, DMAIC
• Leading automation initiatives from concept through to implementation
• Resolving non-conformances and supporting daily manufacturing operations
• Writing URS, validation protocols, and technical reports

What we're looking for:

• Level 8 Engineering degree and 5+ years in medical device or regulated manufacturing
• Hands-on lean manufacturing experience — not just training, but real projects with real outcomes
• Experience writing a URS and leading process and equipment validations
• ISO 13485 and FDA regulatory knowledge
• Someone who is equally comfortable on the manufacturing floor and in front of senior stakeholders
• A self-starter with the ambition to grow with the business