CREGG is hiring for a Manufacturing Engineer to work with a large Medical Device company in Galway. Hybrid role.
Job Summary
The Manufacturing Engineer supports the design, development, validation, and continuous improvement of manufacturing processes for medical devices. This role ensures products are manufactured efficiently, safely, and in compliance with regulatory requirements such as FDA, ISO 13485, and GMP.
Key Responsibilities
Process Development & Optimization
Design, develop, and improve manufacturing processes for medical devices
Create process flow diagrams, work instructions, and standard operating procedures (SOPs)
Optimize processes for quality, yield, cost, and cycle time
Support transfer of products from R&D to manufacturing
Validation & Compliance
Lead and execute process validation activities (IQ/OQ/PQ)
Ensure compliance with FDA regulations (21 CFR 820), ISO 13485, and GMP requirements
Support audits and inspections (FDA, notified bodies, internal audits)
Maintain manufacturing documentation in accordance with quality system requirements
Equipment & Tooling
Specify, qualify, and maintain manufacturing equipment and tooling
Collaborate with suppliers on equipment design and installation
Troubleshoot equipment and process issues to minimize downtime
Cross-Functional Collaboration
Work closely with Quality, R&D, Regulatory Affairs, Supply Chain, and Operations teams
Support design for manufacturability (DFM) and design for assembly (DFA) efforts
Assist in root cause investigations and corrective actions (CAPA)
Apply Lean, Six Sigma, or other continuous improvement methodologies
Drive cost reduction, waste elimination, and efficiency improvements
Analyze process data and implement corrective and preventive actions
Required Qualifications
Education
Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field
Experience
2–7 years of manufacturing engineering experience (level dependent)
Experience in a regulated industry, preferably medical devices
Hands-on experience with process validation and documentation
#J-18808-Ljbffr