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 *****, 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 *****, 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 *****, GMP
Experience with IQ/OQ/PQ validation INDTRAC
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