Manufacturing Engineer - Galway

Manufacturing Engineer - Galway.

Working within the core engineering group as a Manufacturing Engineer, this newly established role will be responsible for supporting the successful transfer of new products into manufacturing and supporting the set-up of a robust, efficient production line.

The Manufacturing Engineer will work closely with cross-functional teams to ensure all processes, equipment, documentation, and controls are in place to achieve a smooth transition from development to full-scale commercial manufacture.

This is a hands-on Engineering role requiring strong technical, problem-solving, and validation skills to drive early-stage optimization and ensure compliance with all ISO13485 regulatory, quality, and safety standards.

Key Responsibilities:

• To execute tasks as assigned within projects and lead assigned work tasks to successful outcomes.
• To implement appropriate process controls for manufacturing processes for robust and repeatable commercial manufacturing.
• To maximize manufacturing process performance through implementation of continuous improvement methodology.
• To apply a scientific approach to problem solving, combining analytical and experimental skills to maximize efficiency.
• To ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
• To support the development of new processes in conjunction with Automation Engineering ensuring that new processes are stable and capable.

• To provide technical support to new product/ technology introductions and ensure changes are effectively managed.
• To ensure that non-conforming products and processes are evaluated and corrected in accordance with process controls and procedures.
• To successfully complete validations and process improvements using statistical tools and six sigma techniques.
• To support the development of in-house Subject Matter Experts (SME) across the range of core technologies.
• To support process/ equipment/ H&S risk assessment and analysis of risk to product or user.

Qualification and Experience Requirements:

• Honors Degree Level 8 in Engineering or equivalent discipline.
• A minimum of 3 – 5 years' professional experience in a responsible Manufacturing Engineering role within the Medical Device/Healthcare sector.

• Thrombectomy/ Atherectomy device manufacturing experience ideal but not essential.
• Experience in laser welding metals would be beneficial.
• Proven and successful implementation of continuous improvement initiatives is essential
• Experience in the scale up of manufacturing processes preferred

• Proficiency in CAD software
• Strong report writing and documentation skills, with high attention to detail.

• Strong knowledge of regulatory requirements and quality standards
• Knowledge of validation and qualification (IQ, OQ, PQ) for equipment and processes.