Job Description

Manufacturing Engineer - Galway

Ref No: AM18576

County Galway, Republic of Ireland

Competitive salary

Manufacturing Engineer - Galway.

Working within the core Engineering group, as an ME you will play a crucial role in the successful manufacture of medical devices. You will leverage your technical expertise, problem-solving abilities, and validation experience to ensure the efficiency and quality of the manufacturing processes.

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 on assigned responsibilities 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.

Education and experience requirements:

• Honors Degree Level 8 in Engineering or equivalent discipline.

• A minimum of 3-5 years of professional experience in a Manufacturing Engineering role within the Medical Device/Healthcare sector.

• Balloon forming experience required. Ability to identify optimal forming parameters for yield and functional performance.

• Proven and successful implementation of continuous improvement initiatives is essential.

• 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.