Job ID: JOB-11498
Our client a leading medical device company in Co.Clare are currently recruiting for a permanent opportunity for a Manufacturing/Process Engineer to join their growing organisation. This position will be commutable from Limerick and Galway.
The person taking up this role will have an equipment engineering background with experience in leading equipment / process validations. A track record in driving continuous improvement on equipment and processes to reduce scrap and improve throughput. Experience in problem solving methodology is highly desirable.
- Provide Engineering support to the AU Value Stream and related equipment from introduction / validation thru to daily running and process improvement.
- Ensure that hourly targets are met by effectively analyzing and then elimination recurring equipment and process problems, utilizing the Danaher Problem Solving Tools where necessary.
- Continuous improvement of production and output with ownership of associated projects including relevant documentation updates.
- Initiate and complete Engineering Change Controls to manage and drive changes including all relevant documentation changes including but not limited to Design Change Assessment, pFMEA updating and validation assessment.
- Work closely with the validation group to initiate, generate and execute validations to support the introduction of new products, process and equipment
- Analyses process, product, material or equipment specifications and performance requirements.
- Utilise problem solving process PSP / DIVE to troubleshoot new products / process / equipment working closely with cross functional team and/or external vendors.
- Continually seek to identify and then manage improvements in process design, layout and operational performance.
- Develop and use visual project management and daily management boards to drive standard work and identify opportunities for improvements.
- Develops User Requirements spec’s and performs validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Evaluate in conjunction with EHS new equipment/processes for environmental impact/effect to eliminate or lessen such impacts/effects.
- Gives technical guidance to Associate Engineers and technicians.
- Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
- Understand and comply with all the regulations governing the quality systems.
- Communicate effectively and clearly on Equipment and process issues, focusing on root cause, status and counter measures.
Education & Experience:
- Bachelor Degree in Engineering (Honours Level 8)
- 3+ Years engineering experience in an industrial environment.
- Experience in Quality assurance, cGMP / FDA QSR / ISO regulations. ISO13485 experience is highly desirable.
- Experience in leading projects.
- A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards.
- General understanding of business unit/group function.
- Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
- Strong problem solving experience with demonstrated experience in use of PSP tools
For further information on this role in Co. Clare please contact Ciaran Fahy on 087-4108620/ email@example.com
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