Senior Process Development Engineer – Medical Devices

Location: Limerick, Ireland

Position Summary

We are seeking an experienced Senior Process Development Engineer to join a leading medical device organisation in County Limerick. The successful candidate will be responsible for the development, validation, and optimisation of manufacturing and packaging processes for catheter-based medical devices, with a particular focus on microcatheter products. This role will support process scale-up, technology transfer activities, test method validation, packaging integration, and process validation in a regulated medical device environment.

Key Responsibilities

• Lead process development activities for new and existing medical device products, ensuring robust, scalable, and compliant manufacturing processes.
• Execute and document process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop, execute, and report on Test Method Validation (TMV) studies in accordance with applicable regulatory and quality standards.
• Support the development, optimisation, and validation of manufacturing processes for microcatheter products.
• Lead packaging development and validation activities, including integration of products into existing packaging systems and production lines.
• Collaborate with Manufacturing, Quality, R&D, Validation, and Supply Chain teams to ensure successful product launches and process improvements.
• Conduct process characterisation studies, root cause investigations, and continuous improvement initiatives.
• Generate and maintain technical documentation, validation protocols, reports, risk assessments, and engineering change documentation.
• Ensure all activities comply with FDA, ISO 13485, MDR, GMP, and internal quality system requirements.
• Provide technical leadership and mentoring to junior engineers and cross-functional teams.

Qualifications & Experience

• Bachelor's Degree in Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or a related discipline.
• Minimum 5+ years' experience within the medical device industry.
• Demonstrated experience working with microcatheter products or similar catheter-based technologies.
• Strong experience executing Test Method Validation (TMV) studies.
• Proven experience in process validation including IQ, OQ, and PQ execution.
• Experience with packaging development, packaging validation, and integration of products into existing packaging systems.
• Strong understanding of statistical analysis, process capability, and validation methodologies.
• Experience working within ISO 13485 and FDA-regulated environments.
• Excellent technical writing, documentation, and communication skills.
• Experience supporting new product introduction (NPI) and technology transfer projects.
• Knowledge of Design Controls, Risk Management (ISO 14971), and Process Characterisation.
• Familiarity with Lean Manufacturing and Six Sigma methodologies.
• Project management experience in a regulated medical device environment

For More Info on this job opportunity contact:
Gary Keane
Call: 086-1030418
Email: [email protected]

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