Location: Cork, Ireland
Hybrid: 3 days onsite, 2 days from home
Rate: Circa €70/hr (DOE)
Duration: 12 Month Contract - strong chance of extension
Travel Requirements: FAT & Build oversight across Scotland, the US, Malaysia, and other international vendor sites.
The Context & Scope
We are supporting a major medical device manufacturer expanding their Cork site. The project involves taking ownership of the design, vendor build, FAT/SAT, and validation setup for 7 to 8 complex, automated production lines handling diverse product streams.
This is an end-to-end delivery role. You will manage the external equipment integrators, oversee machine builds, prove out process capability, and prepare the assets for site validation and handover.
This is the ideal next step for a Senior Automation Engineer or a Project Engineer ready to advance into global delivery. Designed for someone who built their foundation in hands on technical execution, managing machine builds and vendor interactions, this role offers the opportunity to step up into a fully project-focused, global project leadership position.
You will sit at the center of the project: managing external equipment integrators, overseeing machine builds globally, proving out process capability, and driving handover into validation.
Core Responsibilities
- Vendor Management & Build Oversight: Serve as the primary technical interface for machine builders and integrators globally. Drive design reviews, risk assessments, FATs, and SATs.
- Systems Integration: Lead technical execution across machine vision, robotics, multi-axis servo motion, PLCs/HMIs, and high-speed mechanical assembly.
- Process Characterisation: Oversee process capability, cycle-time optimization, and statistical characterisation (GR&R, MSA) ahead of validation.
- Validation Setup: Develop user requirements, equipment specs, and test protocols to ensure equipment seamlessly enters formal IQ/OQ/PQ under ISO 13485 / FDA regulations.
- Global Delivery: Travel extensively during equipment build and FAT stages (US, Europe, Asia) to troubleshoot, sign off, and clear equipment for shipment.
Technical Profile Required
- Minimum 5 years of hands-on automation delivery within Medical Devices
- Proven background bringing bespoke automated machinery from initial vendor design concepts through build oversight, FAT, installation, and process handover.
- Solid background holding vendors accountable to technical specifications, budget, and delivery schedules.
- Strong working knowledge of GAMP, ISO 13485, and statistical tools used for machine qualification.
- Willingness to travel internationally for equipment FATs and build milestones.
How to Apply: Send your CV directly or hit apply below to discuss the project details.
