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Manufacturing Engineer

Job description

Manufacturing Engineer | Medical Device Company

The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the production/manufacturing department.

Location:  Co. Galway

Pay/Benefits:

  • Attractive Salary
  • 4-day working week
  • Annual Bonus
  • VHI health Insurance for the employee (spouse and kids if applicable)
  • Defined Contribution pension
  • Stock options grant available
  • Long term disability + Death in service cover up to 4x lump sum salary
  • Flexible working week (four days working week)
  • Free car parking onsite
  • Canteen facilities onsite
  • Paid Holidays

Responsibilities of the Job:

  • Provide technical support on all product and processing related issues.
  • Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved.
  • Experienced in Product Transfers and Manufacturing process set up and scale up.
  • Apply “Lean” principles to production lines considering flow optimisation, throughput time, product movement, layout and space.
  • Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment.
  • Set up Preventive Maintenance and Calibration routines.
  • Provide ongoing day to day support to Production; continually seeking to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot production related issues, implementing “robust permanent fix” solutions.
  • Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Work Instructions, Manufacturing procedures and Logs.
  • Set up and order Product, Components, Consumables, and Material necessary for validation and production.
  • Manage Tooling and Equipment spare parts inventory to support manufacturing capacity.
  • Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
  • Partner with R&D, Quality and Operations to ensure that the transition of Balloon products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective. 

What we would like you to have:

  • Engineering Degree or equivalent.

  • A minimum of 3 years’ experience working in a similar role. Catheter manufacturing knowledge is highly desirable.

  • Strong technical understanding of set up and maintenance of manufacturing processes.

  • Experience in validation, equipment design and Lean Manufacturing highly desirable.

  • Equipment Procurement and Validation experience.

  • Has conducted IQ/OQ/PQs and/or validations previously in a regulated environment. 

If you are interested in this job and are a suitably qualified and experienced Senior Engineer, please contact Aaron Long at Sigmar Recruitment T: +353 91 749 264 | E: along@sigmar.ie

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