Job Description
A Manufacturing Engineer is required for our Galway‑based Medical Devices client. Reporting to the Group Engineering Lead, you will play a crucial role in manufacturing a medical devices product, ensuring the efficiency and quality of manufacturing processes. Suitable candidates must have at least 3 years of Balloon Forming experience.
Responsibilities
Execute tasks as assigned within projects and lead work tasks to successful outcomes.
Implement appropriate process controls for manufacturing processes to achieve robust and repeatable commercial manufacturing.
Maximise manufacturing process performance through continuous improvement methodology.
Apply a scientific approach to problem solving, combining analytical and experimental skills to maximise efficiency.
Ensure that all engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
Support the development of new processes in conjunction with Automation Engineering to ensure they are stable and capable.
Provide technical support to new product/technology introductions and ensure changes are effectively managed.
Ensure non‑conforming products and processes are evaluated and corrected in accordance with process controls and procedures.
Successfully complete validations and process improvements using statistical tools and Six Sigma techniques.
Support the development of in‑house Subject Matter Experts across core technologies.
Support process, equipment, H&S risk assessment and analysis of risk to product or user.
Qualifications
Honours Degree Level 8 in Engineering or equivalent discipline.
Minimum of 3–5 years of professional experience in a responsible Manufacturing Engineering role within the Medical Device/Healthcare sector.
Balloon forming experience; ability to identify optimal forming parameters for yield and functional performance.
Proven and successful implementation of continuous improvement initiatives.
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.
Responsible for providing regular progress updates to senior management and leading or participating in routine manufacturing meetings to support operational goals.
Maintain metrics and report weekly on each metric.
#J-18808-Ljbffr