Senior Manufacturing Engineer

Work Flexibility: Onsite

Senior Manufacturing Engineer

• Contract: Permanent + full suite of benefits
• Location: Model Farm Road, Cork
• Business Area: Neurovascular
• On-Site Position

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!

We are proud to offer you our comprehensive rewards package, which includes bonuses, healthcare, insurance benefits, retirement programs, wellness initiatives, service and performance awards, as well as various social and recreational activities – all tailored to your location.

Position Summary

The Senior Manufacturing Engineer will play a key role in driving the integration of automation within the neurovascular value stream, ensuring precision assembly, robust inspection, and full compliance with regulatory standards. This high-visibility role sits at the intersection of operations, IT/OT, and quality, with responsibility for developing and validating advanced manufacturing systems to support life-saving neurovascular products.

Key Responsibilities

•    Design, develop, execute, and evaluate fitness-for-use testing, product specifications, and process validation plans.
•    Create and review material part specifications and bills of materials.
•    Collaborate with internal manufacturing partners, contract manufacturers, designers, and product specialists to optimise designs for manufacturability.
•    Utilise CAD (Computer Aided Design) and CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.
•    Lead and support validation activities (IQ, OQ, PQ) for manufacturing processes, fixtures, and automation systems.
•    Drive continuous improvement initiatives through Lean and Six Sigma methodologies, focusing on automating manual processes, enhancing process robustness, and reducing costs.
•    Provide frontline support for advanced manufacturing systems, including automation, IT/OT integration, and vision/PLC-controlled inspection systems.
•    Ensure compliance with FDA, ISO, and internal quality standards in all manufacturing and validation activities.
•    Operate as an individual contributor with professional judgment, expected to work independently with minimal supervision.
 

Qualifications, Knowledge & Skills

• Level 8 Degree in Engineering or equivalent technical experience.
• 2–4 years’ experience in a manufacturing environment (medical device or regulated industry preferred).
• Strong communication and influencing skills with both internal and external stakeholders.
• Proven ability to work cross-functionally with Advanced Operations, Quality, and other departments.
• Analytical and problem-solving skills with a process improvement orientation.
• Experience working in a Six Sigma and Lean Manufacturing environment, with proven improvement results.
• Six Sigma Green or Black Belt certification preferred.
• Demonstrated ability to work autonomously and as part of a multi-disciplinary, dynamic team.
• Flexible team player, capable of handling multiple tasks in a fast-paced environment.
• Experience in an FDA-regulated industry or equivalent is highly beneficial.

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