Job Description
We are partnering with a leading medical device company to hire a Senior Manufacturing Engineer to join their growing team in Galway, Ireland. This role offers the opportunity to play a key part in developing and optimising advanced manufacturing processes for Class II/III medical devices, supporting business growth and ensuring compliance with the highest international standards.
This position is ideal for an experienced engineer with strong leadership skills, a passion for continuous improvement, and a proven track record in medical device manufacturing.
Key Responsibilities
* Provide technical leadership and mentorship to engineers and technicians, ensuring stable, efficient, and compliant manufacturing operations.
* Lead complex troubleshooting efforts for equipment, tooling, process, or material issues using advanced problem-solving techniques.
* Drive continuous improvement initiatives using Lean, Six Sigma, and other structured methodologies.
* Own and oversee process and equipment change control activities, ensuring quality and regulatory compliance.
* Lead the strategy, planning, and execution of equipment and process validations (IQ, OQ, PQ).
* Guide root cause investigations for non-conformances and ensure effective corrective and preventive actions (CAPA).
* Collaborate cross-functionally on new product introductions, risk management (. FMEAs), and technology transfers.
* Represent manufacturing engineering in audits and regulatory inspections, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR.
Required Skills and Qualifications
The ideal candidate will possess:
* Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical or related discipline).
* 6–9 years' experience in medical device or pharmaceutical manufacturing, with proven leadership and mentoring responsibilities.
* Strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR).
* Demonstrated expertise in process validation (IQ/OQ/PQ) and change control.
* Skilled in continuous improvement methodologies (Lean, Six Sigma – Green Belt preferred).
What’s on Offer
* Opportunity to work on cutting-edge MedTech manufacturing processes.
* Career development with leadership exposure and cross-functional project ownership.
* Competitive salary and benefits package.
* Collaborative and innovative team environment.