JOB TITLE: Manufacturing Engineer
REPORTING TO: Technical Director
LOCATION: Shannon, Co. Clare
Type: Full time, permanent
My Shannon based client, a precision tools manufacturer is currently looking to recruit an experienced Manufacturing Engineer to support manufacturing through the continuous development and improvement of manufacturing processes and support day to day operations to achieve targets. Provide project leadership on continuous improvement and risk mitigation initiatives. Liaise with outside suppliers, engineering and other departments to ensure all goals and targets of the manufacturing process are achieved.
o Support key business metrics with ongoing process improvements and introduction of new manufacturing processes and technologies.
o Prepare and complete validation documentation (URS, IQ, OQ, PQ & validation reports) and oversee the execution of protocols for equipment and processes.
o Manage the execution of the process validation as per the MVP and project plan. Ensure all results and data are correct and follow-up on any gaps or discrepancies.
o To understand, learn and develop operating programs for a range of equipment and to become the Subject Matter Expert (SME) for specific assigned processes and equipment.
o Work with the clients Engineering Team and external suppliers to develop production processes and technologies.
o Develop product technical files, including SOP, Validations and Test Methods.
o Implement appropriate process controls on to manufacturing processes for robust and repeatable product manufacturing. (Maximize manufacturing process performance through effective implementation of LEAN SIGMA methodology.
o Apply a scientific approach to problem solving, combining analytical and experimental skills to maximize overall equipment effectiveness and efficiency.
o Ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
o Identify and eliminate repetitious machine failures.
o Provide consultative support to the Manufacturing and Maintenance.
o Utilize Lean Six Sigma tools and data to drive continuous improvement.
o Develop and Implement Safety and Quality improvements.
o Fault-finding \ troubleshooting of equipment and process issues.
o Installation, Commissioning and Validation of automation lines.
o Implement improvements under change control.
o Coordinate the development of documentation in the Production and Technical areas in line with ISO9001 and ISO 13485 requirements,
o Manage production support, new product introduction, process improvement for a number of product lines across a wide range of CNC controlled and manual production equipments.
o Support process Engineers with product costing, process improvement, subcontract operations and industrial studies.
o Support production in resolving product and process issues.
o Documentation & Procedures
- full job description available on request
KNOWLEDGE SKILLS AND EXPERIENCE
A Degree qualification in Mechanical and/or Manufacturing Engineering is essential, preferably coupled with a final year project/industrial placement within the Medical Device /Aerospace Industry.
A minimum of 3 year experience in technical role.
Confident in validation requirements on new equipment introductions, processes and process changes.
Strong analytical approach to problem solving to deliver innovative solutions
Experience implementing Continuous Improvement methodologies and programs such as Six Sigma, DMAIC, Change Management and Lean Manufacturing with strong analytical skills
High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
Medical device/Aerospace experience preferred.
Experience working in a validated environment with strong discipline with regard to change control is preferred
Must be able to read and interpret engineering drawings and have a good understanding of geometrical dimensioning and tolerance
Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. work instructions, inspection procedures, capital proposals).
Working knowledge of CNC Machine Tools & NC programming
Working knowledge of CAD/CAM/CAE computer systems
Strong knowledge of MS Office
Working knowledge and understanding of quality systems and inspection tools
PERSONAL SKILLS AND ATTRIBUTES
* Ability to prioritise work effectively and multiple task
* Positive attitude and be motivated by the role
* Operates to the highest ethical, professionalism standards with a strong work ethic
* Willingness to be flexible and driver of change
* Use creative approaches to achieve goals
* Excellent interpersonal communication skills (Verbal and Written)
* Good problem solving skills using Lean & Six Sigma tools.
* Sets and achieves aggressive improvement goals
* Excellent analytical skills
* Strong project and time management skills
To apply for this role, please submit your CV (in Word) now, or for additional information please call Renata Ryan on 0860239020