We are seeking an enthusiastic and ambitious Process Engineer to join our dynamic medical device/component processing team in Boyle, Ireland.
The Process Engineer will be a key technical leader within the manufacturing team, responsible for driving continuous improvement, supporting day-to-day operations, and delivering waste elimination initiatives. This role will interface directly with customers on product development and complaint investigations, while also supporting the introduction of new technologies and processes. Operating in a fast-paced, quick-turnaround environment, the Process Engineer will ensure robust, efficient, and compliant manufacturing processes that meet internal and external expectations
Role and Responsibilities
The ideal candidate has experience in successfully leading x-functional problem-solving teams with the skills necessary to seek out and eliminate waste. You will liaise with quality, sales, customers, and suppliers regarding technical production issues.
You will also:
* Act as the technical lead for assigned production areas, supporting delivery of key performance metrics including yield, uptime, and quality.
* Lead and support CI initiatives focused on waste elimination, cost reduction, and process optimization using Lean and Six Sigma methodologies.
* Own and drive structured investigations into customer complaints and internal non-conformances, ensuring timely root cause analysis and effective CAPA implementation.
* Collaborate with cross-functional teams to introduce and validate new equipment, technologies, and processes.
* Provide technical support for the transfer and scale-up of new products into manufacturing, including documentation, training, and process readiness.
* Maintain strong communication with customers, suppliers, and internal stakeholders to resolve technical issues and support development activities.
* Champion a hands-on, data-driven approach to problem solving and process improvement.
* Ensure compliance with quality system requirements, GMP, 6S, and safety standards.
* Support training and development of operators and technicians to build technical capability across the team.
* Maintain effective documentation and reporting in line with site and divisional standards.
Skills and Qualifications
* Bachelor’s degree in Polymer, Mechanical, Manufacturing Engineering or related discipline.
* Minimum 3 years’ experience in a manufacturing/process engineering role, ideally within the medical device or regulated industry.
* Proven experience in process improvement, waste elimination, and structured problem solving.
* Hands-on experience with extrusion or polymer processing is a strong advantage.
* Familiarity with ISO 13485, FDA, and quality system requirements.
* Lean Six Sigma Green Belt or higher preferred.
* Project Management skills.
* Communication skills – verbal, written and presentation.
* Good statistical and data analysis knowledge (minitab experience is beneficial).
* A high degree of flexibility in a continuously changing environment.
Travel Required: Minimal