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Manufacturing Engineer

Job description

Looking for a Manufacturing Engineer with at least three years’ experience in the Medical Device industry for a role with an expanding Medical Device company in Co. Galway. This is a four-day week role as the plant is closed on Friday.

Key Responsibilities:

  • 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 validation
  • 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

Key requirements:

  • 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
  • Proven technical expertise and competence across all aspects of manufacturing engineering function including lean.
  • Demonstrated expertise and detailed knowledge of the medical device industry.
  • Equipment Procurement and Validation experience
  • Has conducted IQ/OQ/PQs and/or validations previously in a regulated environment. Effective knowledge of the regulatory environment in which the business operates.
  • Proven written and oral communication skills and an ability to prepare competent business cases.
  • An analytical approach to problem solving
  • Good oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
  • Ability to stay connected to multiple projects simultaneously.

If you are interested in this role, please send your resume to mslevin@sigmar.ie or call me on 091 455 300.

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