Process Development Engineer

We have a current opportunity for a Process Development Engineer on a contract basis. The position will be based in Galway. For further information about this position please apply.

We are seeking a highly motivated Process Development Engineer to join our dynamic team in the medical device sector. This role is critical in supporting the development and introduction of innovative products through robust process design, equipment qualification, and mechanical development.

Key Responsibilities:

• Lead and support equipment qualification activities, including IQ/OQ/PQ documentation and execution.
• Drive mechanical design and development of components and systems for new and existing products.
• Collaborate cross-functionally to support New Product Introduction (NPI) initiatives, ensuring smooth transition from concept to production.
• Apply design experience to develop and optimise manufacturing processes and tooling.
• Contribute to exploratory projects aimed at advancing product development and improving process capabilities.
• Ensure compliance with relevant medical device regulations and standards (e.g., ISO 13485, FDA, MDR).

Qualifications & Experience:

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Proven experience in process development within the medical device or regulated industry.
• Strong understanding of equipment qualification protocols and documentation.
• Hands-on experience with mechanical design tools (e.g., SolidWorks, AutoCAD).
• Familiarity with NPI processes and cross-functional project management.