Job Description
Our state-of-the-art facility in Fermoy, Ireland is FDA registered and certified to ISO13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.
We specialize in manufacturing automation and provide services throughout the product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair.
The facility has a 30-year track record of outstanding operational performance and customer service, backed by a highly experienced workforce.
Responsibilities:
* Maintain automation equipment of a Class III Medical Device in excellent condition to ensure consistent quality, output, and yield.
* Follow systematic root cause problem solving and troubleshooting to resolve issues.
* Carry out preventative and corrective maintenance, completing all associated paperwork and records.
* Lead and implement process improvements to achieve more efficient operations while adhering to change management and cGMP requirements.
* Assist with the commissioning of new equipment/projects.
* Order and maintain appropriate stock of spare parts.
* Cross Train technicians as required.
* Flexible to travel to support new equipment buy-offs/training.
Essential Requirements:
* Minimum Level 6 qualification in Manufacturing Technology, Mechanical/Automation Engineering, Electrical, Electronics, Mechatronics or qualified trade personnel.
* 2 years experience as an SMT Technician.
* Experience in high volume automation/robotics.
* Good communication and influencing skills.
* Ability to work under own initiative.
* Availability to work shift patterns.
Desirable:
* Experience in Pneumatics, Electronics, Hydraulics, Programmable Controllers, Servo Motor drives, Vision systems, Ultrasonic welding, workshop machining.
* Understanding of Process Capability.
* Understanding of MSA (Measurement System Analysis) & GR&R (Gauge Repeat & Reduction).
* Experience in FAT (Factory Acceptance Test), SAT (Site Acceptance Test), IOPQ (Installation, Operation, Performance Qualification) automated assembly lines.
* Experience in leading process improvement projects in medical device environment.