Our client, an innovative and expanding Medical Devices organisation in Galway offers total solutions to ensure the design and manufacture of market leading products. With a world class development team this organisation is an exciting place to be due to expansion on-going and new projects in the pipeline at their Galway site.
Our client in Galway has a need for a Manufacturing Engineer to join their team, where you will report into the Manufacturing and Facilities Engineering Manager, you will hit the ground running and become a key member of the Engineering team predominantly working with setting up manufacturing processes, ensuring successful scale up and NPI.
- Develop, optimise and validate new product manufacturing processes, and improve existing.
- Manage the successful scale up and commercialisation of new processes ensuring target yield, capacity, throughput time and productivity are achieved.
- Specification, Procurement, Installation, and Validation of Manufacturing Equipment.
- Lead the transfer of new manufacturing processes and provide training to production personnel.
- Establish and maintain appropriate Manufacturing documentation and 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.
- 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.
As the successful Manufacturing Engineer, you will posess:
- An Engineering Degree or equivalent, with a minimum of 3 years industry experience in a similar role within medical devices.
- Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design and Lean Manufacturing highly desirable within the medical device industry.
- Experience in Product Transfers and effective knowledge of FDA and ISO regulatory environments.
- Effective knowledge of balloon manufacturing desirable.
- Health Insurance (family inclusive)
- Flexible working week
To learn more, apply online or contact Caroline Geraghty at HRM directly on +353 91 782114 for a confidential chat.
Salary: On Application
Location: Galway city