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.