Manufacturing Engineer – New Product Transfer New

Manufacturing Engineer – New Product Transfer

Galway (on-site, flexible core hours, Monday - Friday)

Permanent, full time

About the role

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.

• 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.

• 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.

• 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 [email protected]