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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