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Senior Process Development Engineer
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Tommy McKeown
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Permanent
Senior Process Development Engineer
Role Overview
Responsible for developing, validating, and improving robust and scalable manufacturing processes for medical device production. The role combines process development, manufacturing support, automation, continuous improvement, troubleshooting, and regulatory compliance.
Key Responsibilities
Education & Experience
Role Overview
Responsible for developing, validating, and improving robust and scalable manufacturing processes for medical device production. The role combines process development, manufacturing support, automation, continuous improvement, troubleshooting, and regulatory compliance.
Key Responsibilities
- Develop, optimise, and validate manufacturing processes to meet quality, cost, efficiency, and production targets.
- Work closely with engineering and production teams to troubleshoot issues and improve process performance.
- Lead automation initiatives, including the implementation of vision systems, robotics, and digital monitoring technologies.
- Drive continuous improvement using Lean methodologies such as DMAIC, Kaizen, and Value Stream Mapping.
- Apply structured problem-solving to process, material, equipment, and quality issues.
- Develop and maintain manufacturing procedures, work instructions, and operational documentation.
- Conduct process analysis and identify opportunities to improve productivity, reliability, and scalability.
- Develop experiments, validation protocols, analyse results, and prepare technical reports.
- Support the investigation and resolution of CAPAs, non-conformances, and audit observations.
- Develop training materials and support knowledge transfer to manufacturing teams.
- Evaluate new technologies based on performance, cost, reliability, and suitability for manufacturing.
- Provide hands-on support to day-to-day manufacturing operations.
Education & Experience
- Level 8 degree in Engineering or a related discipline.
- 5+ years of relevant engineering/manufacturing experience.
- Medical device process development and manufacturing experience.
- Experience with project/program management and process validation.
- Strong knowledge of risk analysis, structured problem-solving, and continuous improvement.
- Understanding of Lean, Six Sigma, DOE, and statistical techniques.
- Knowledge of ISO 13485 and FDA regulatory requirements.
- Experience with engineering/design software such as AutoCAD or SolidWorks.
- Green Belt certification is advantageous.
- Strong communication, organisational, teamwork, and project ownership skills.
