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