Manufacturing Engineer

SIGMAR RECRUITMENT

GALWAY

Looking for an experienced Manufacturing Engineer for a Medical Device company in Co. Galway. This is a four day week role. Keyresponsibilities: Provide technical support on all product and processing related issues. Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved. 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. Keyrequirements: 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. Ifyouareinterestedinthisrole,pleasesendyourresumetomslevin@sigmar.ieorcallmeon091455300formoreinformation. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1596 days ago