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.
Job Types: Full-time, Permanent
Work Location: In person
