Manufactruring Engineer (NPI)

NPI Manufacturing Engineer (Hybrid)

CREGG are hiring an experienced Manufacturing Engineer to work with a large Medical Device company in Galway. Hybrid role. Ideal candidate comes from a strong New Product Introduction background and has full time work permit.

For more information contact Rachel:

Job Summary Hybrid role offering 2 days work from home. 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

• Design, develop, and improve manufacturing processes for medical devices
• Create process flow diagrams, work instructions, and standard operating procedures (SOPs)
• 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
• Collaborate with suppliers on equipment design and installation
• Troubleshoot equipment and process issues to minimize downtime
• 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

Education

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field

Experience

• 2-7 years of manufacturing engineering experience (salary related to experience)
• Experience in a regulated industry, preferably medical devices
• Hands on experience with process validation and documentation
• Knowledge of FDA QSR, ISO 13485, GMP
• Experience with IQ/OQ/PQ validation INDTRAC