Process Engineer Opportunity
We are seeking a highly skilled Process Engineer to join our team in Cork. This is a key role in the development, optimization, and sustainment of manufacturing processes for advanced neurovascular medical devices.
About the Role
* You will play a vital part in developing and optimizing manufacturing processes to ensure product quality, process stability, and regulatory compliance.
* You will lead root cause analysis and implement corrective actions to address product and process issues.
* You will identify and deliver continuous improvement projects focused on OEE, yield, and scrap reduction using Lean, Six Sigma, and statistical techniques.
* You will execute process and equipment changes under our quality system, including documentation, risk assessment, validation, and change control.
* You will support ongoing process validation and maintain a validated state through periodic reviews and revalidations as required.
* You will partner with Production, Quality, Maintenance, and Supply Chain teams to improve equipment uptime, throughput, and reliability.
* You will lead data collection, analysis, and reporting on key performance metrics and drive improvements based on findings.
* You will support and lead audits, CAPA closure, and documentation updates to ensure compliance with ISO 13485 and FDA QSR standards.
* You will train and mentor technicians and operators on process changes, standard work, and best practices to foster a culture of continuous improvement.
Key Qualifications
* Bachelor's degree in Manufacturing, Mechanical, Industrial, or Biomedical Engineering (or related discipline).
* Minimum 2+ years of experience in manufacturing or process engineering, ideally in a regulated medical device or high-volume precision assembly environment.
* Proven expertise in continuous improvement, process optimization, and problem-solving (Lean/Six Sigma Green Belt preferred).
* Strong understanding of manufacturing documentation, change control, and validation processes.
* Solid experience with CAPA management, risk analysis (PFMEA), and troubleshooting production issues.
* Excellent interpersonal and communication skills with the ability to influence and work cross-functionally.
* Strong technical judgment and a hands-on approach to resolving complex engineering challenges.
Why Join Us?
This is a fantastic opportunity to be part of a world-class Neurovascular manufacturing hub focused on precision, safety, and innovation. You will collaborate with a talented, diverse team committed to operational excellence and grow your career in a globally recognized organization that invests in its people and values integrity, accountability, and inclusion.