Start the New Year with a new job.
I'm looking for experienced Manufacturing Engineers for expanding multinatinals and a small medical device company that operate on a 4 day week.
- Set up a new Manufacturing Process.
- Manage the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved.
- Design, procure and construct “Lean” production lines taking into account 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.
- Lead the knowledge transfer of this new manufacturing process and provide training to product builders and technicians.
- Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot issues implementing “robust permanent fix” solutions.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
- Set up and order Product, Components, Consumables, and Material necessary for validation and production.
- Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
- Generate and gain approval for project budgets and subsequently manage expense and capital expenditure in line with this budget.
- Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
Background and Experience:
- NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
- Minimum 3-5 years’ experience working at an Engineering level, ideally in Medical Device industry or other highly regulated environment
- Project Management experience highly desirable
For more information, please contact Emma on 091 455 307.
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.