Manufacturing Engineer - Galway

Co Galway
Permanent
Full-time

1 month ago
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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.

ICDS Recruitment