Manufacturing Engineer - Galway

Manufacturing Engineer - Galway.

In this role 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 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 appropriately to 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.

QUALIFICATIONS AND EXPERIENCE REQUIREMENTS:
• Honours Degree Level 8 in Engineering or equivalent discipline
• A minimum of 3-5 years' professional experience in a Manufacturing Engineering role within the Medical Device/Healthcare sector

• 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.