Manufacturing Engineer Hybrid

Manufacturing Engineer 

CREGG are hiring for a Manufacturing Engineer to work with a large Medical Device company in Galway. Hybrid role

For more information contact Mark: 086 1901346 or [email protected]

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)

Continuous Improvement

• 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

Technical Skills

• Knowledge of FDA QSR, ISO 13485, GMP

• Experience with IQ/OQ/PQ validation

  INDTRAC