Job Overview
This is an exciting opportunity to optimize manufacturing processes for a renowned medical device company in Enniscorthy, Ireland.
The Medical Device Process Optimization Expert plays a crucial role in ensuring all manufacturing processes are run safely and efficiently, reporting to the Engineering Manager or Lead.
About Our Company
We design, develop, and manufacture innovative minimally invasive medical devices for various applications.
The team brings novel solutions to market, continuously improving internal equipment to maintain flexibility.
Responsibilities
* Participate in project teams with engineers, technicians, and professionals to improve product, equipment, and fixture processes on the manufacturing line.
* Initiate and develop process validations, software validation, and equipment validations.
* Design, develop, and optimize complex equipment.
* Perform engineering work, including process/product improvements, test of materials, specification preparation, process study, evaluation of process models, development improvement of equipment, tools, fixtures, and report preparation.
* Understand and perform Project plans, risk analysis project updates, and Project implementation for complex projects.
* Understand and create Process FMEA (Failure Mode Effects Analysis) review and update.
Requirements
* Bachelor's degree in engineering plus two years' experience (ideally in medical devices) or Master's degree in a technical field.
* GMP experience is a distinct advantage.
* Eligible to work in Ireland, existing work permit or EU passport required.