An opportunity has arisen for an experienced Senior Manufacturing Engineer to join an advanced start up medical device company in Galway. The Senior Manufacturing Engineer will lead the engineering support for the manufacturing lines and implement projects to improve process capabilities, yields, scalability and COGS.
This is a permanent position and will offer excellent exposure to the successful candidate both internally and with vendors. There will be significant scope for cross functional communication, stakeholder management and long term progression.
Responsible for production line set-up, equipment operation and maintenance, including calibration and preventative maintenance.
Identify and implement changes that will improve the line output and yields.
Drive the COGS reduction and manufacturing scalability projects at the line level.
Monitor, investigate, resolve, and report on operational issues, opportunities, and development project plans.
Plan, document & conduct manufacturing process and equipment validation activities.
Support design transfer of new products from R&D into manufacturing.
Participate with R&D in design phase on DFM for new products.
Provide training and mentoring to Operations team members on equipment, processes, inspection, etc.
Develop work instructions, visual standards, and test methods.
Manage and execute process and equipment validation.
Manage first article Inspection process, test method development and risk management.
Maintain technical documentation in accordance with Quality System requirements.
Third level qualification in Engineering, Manufacturing, Production, or related discipline.
Working knowledge of quality standards including ISO 13485, MDD, MDR and FDA requirements.
For a more detailed and confidential discussion on this role contact Amy Newell.