Our highly regarded Healthcare Client in the Midwest has a requirement for a Process/Manufacturing Engineer as a result of expansion and NPI. This role would suit someone looking for a hands on role with a company who have a great culture and offer an excellent work/life balance, great benefits/flexi time etc
The person taking up this role will ideally have an equipment engineering background with experience in 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 Value Stream and related equipment from introduction / validation through to daily running and process improvement.
- Ensure that hourly targets are met by effectively analyzing and then elimination recurring equipment and process problems
- 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)
- 3-5yrs+ 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.
- Strong problem solving experience with demonstrated experience in use of PSP tools
Interested candidates should apply online and a member of the team will be in touch
All applicants should be eligible to work in Ireland