Manufacturing Engineer – New Product Transfer
Galway (on-site, flexible core hours, Monday - Friday)
Permanent, full time
About the role
Our client, a growing medical device manufacturer in Galway, is looking for a Manufacturing Engineer to lead a high‑profile new product transfer from a US site into their Galway facility. You will take a complex thrombectomy catheter product from development/overseas manufacture into a robust, efficient, fully validated production line on site. This is a hands‑on role, working closely with R&D, Automation and Operations to make sure the line is stable, compliant and ready for future FDA approval.
What you will do
Own and support the transfer of a new thrombectomy catheter product from a US site into the Galway manufacturing facility.
Set up and optimize a robust production line, ensuring processes, equipment, documentation and controls are in place for repeatable, commercial‑scale manufacture.
Implement and maintain strong process controls and drive continuous improvement on yield, scrap, downtime and efficiency.
Plan and execute equipment and process validations (IQ/OQ/PQ), using data and statistical tools to prove process capability and stability.
Troubleshoot non‑conformances and line issues, identify root causes and implement effective corrective and preventive actions.
Work closely with R&D and Automation Engineering to introduce new processes and technologies, ensuring they are stable and capable before handover to operations.
Ensure all engineering work complies with ISO13485, GMP, regulatory and EHS standards.
Prepare clear technical documentation and reports, and provide regular updates to the Group Engineering Lead and wider leadership team.
About you
Degree (Level 8) in Engineering or a related discipline.
3–5 years’ experience in a Manufacturing / Process / Validation Engineering role in the medical device or healthcare sector (or similar regulated environment).
Proven experience in new product introduction or product transfer into manufacturing; experience transferring from a US site is a strong plus.
Solid experience with process validation (IQ/OQ/PQ) and continuous improvement, ideally using statistical tools and Six Sigma methods.
Comfortable working in a cleanroom, on the line, solving real‑time issues with production and quality.
Strong documentation and report‑writing skills with excellent attention to detail.
Thrombectomy / atherectomy device experience and/or laser welding experience is desirable but not essential.
A collaborative team player who can work closely with R&D, Quality, Automation and Manufacturing Operators.
What’s on offer
Permanent role in a growing Galway site with c.150 employees and increasing manufacturing activity.
Opportunity to be the key Manufacturing Engineer for a flagship new product transfer and future line expansions.
Day‑shift role with flexible core hours and a comprehensive benefits package (including healthcare, dental, contributory pension and other standard benefits).
If you’re a hands‑on Manufacturing Engineer who enjoys new product transfers, validation and building robust processes in a regulated environment, we’d love to hear from you. Apply today or send your CV to Emily.Blinkhorn@cpl.ie
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