Manufacturing Engineer (Balloons)

A Manufacturing Engineer is required by CareerWise Recruitment for our Galway based Medical Devices client. Reporting to the Group Engineering Lead and working within the core Engineering group, as a Manufacturing Engineer you will play a crucial role in the successful manufacture of a medical devices product. You will leverage your technical expertise, problem-solving abilities, and validation experience to ensure the efficiency and quality of our manufacturing processes. Suitable candidates for this Permanent (ON-SITE) day shift role must have at least 3 years Balloon Forming experience.

THE ROLE:

• 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.
• Support the development of in-house Subject Matter Experts (SME) across the range of core technologies.
• Support process/ equipment/ H&S risk assessment and analysis of risk to product or user.

REQUIREMENTS:

• Honors Degree Level 8 in Engineering or equivalent discipline.
• A minimum of 3-5 years of professional experience in a responsible Manufacturing
• Engineering role within the Medical Device/Healthcare.
• 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.
• 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.