Manufacturing Engineer

Cpljobs (Cork City, Ireland) 6 days ago

Job Description


  1. Initiate, co-ordinate and complete assigned projects within the engineering department, using structured approach and detailed planning to deliver projects that meet or exceed stakeholder expectations and that are delivered Right First Time, safely, on schedule and within budget.
  2. Complete Process / Product Validations within the department as they arise, in conjunction with Quality/Validation group.
  3. Support Equipment Validations within the department as they arise, in conjunction with Quality/Validation group.
  4. Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows.
  5. Prepare & execute OQ / PQ protocols for process / material changes as needed.
  6. Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
  7. Liaise with operations and technician group to prepare plan for validation builds.
  8. Co-ordinate the execution of OQ / PQ builds.
  9. Prepare OQ / PQ validation reports and deviations as required.
  10. Conduct process capability analysis using Minitab.
  11. Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.

 Working Knowledge of the following would be an advantage but not a requirement

    • Automated / Semi Automated assembly equipment.
    • Injection moulding and mould tools.
    • High precision Punch & Die Sets.
    • Heat sealing, ultrasonic welding, leak testing, vision systems.
    • OEE Line performance methodology.
    • Minitab/ Lean 6 Sigma techniques
    • Root Cause Analysis methodology
    • Microsoft Excel to an advanced level


    Education: Degree in Mechanical / Production Engineering or equivalent years of experience.

    Experience: Minimum of 3 years relevant experience, preferably within Medical Device industry or other regulated environments.

    Working knowledge of Product & Process validations essential.

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