Manufacturing Engineer (Medical Device)- Galway.

General Description of role:

Your role is to maximise the performance (quality, output volume, & cost of manufacturing processes, by providing high impact technical/operational support, and by developing processes to the highest possible standards.

You will co-ordinate and complete complex projects supporting the implementation of LEAN Manufacturing successfully
against challenging timelines.

Role & Responsibilities

• To implement appropriate process controls on to manufacturing processes for robust and repeatable commercial product manufacturing.
• To maximise manufacturing process performance through effective implementation of LEAN SIGMA methodology.
• To apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness and 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 lead the conversion of manufacturing processes from batch manufacturing to single piece continuous flow manufacturing.
• To support the development of new processes in conjunction with Process/Manufacturing/R&D Engineering ensuring that new processes are stable and capable.
• To provide adequate technical support to new product introductions and ensure change controls are effectively managed.
• To ensure that non-conforming products and processes are evaluated and corrected on assigned projects 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.

Qualifications and Education Requirements

• Catheter manufacturing experience would be an advantage.
• A minimum of 5 years' professional experience in a responsible Manufacturing Engineering/ Process Development role within the Medical Device/Healthcare sector
• Six Sigma Green or Black Belt will have a significant advantage
• Proven implementation of Lean Manufacturing experience essential
• Degree in Mechanical Engineering /Manufacturing Engineering or similar