Manufacturing Engineer Hybrid
CREGG Recruitment View all jobs
- Galway
- Permanent
- Full-time
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 ResponsibilitiesProcess Development & OptimizationDesign, develop, and improve manufacturing processes for medical devicesCreate process flow diagrams, work instructions, and standard operating procedures (SOPs)Optimize processes for quality, yield, cost, and cycle timeSupport transfer of products from R&D to manufacturingValidation & ComplianceLead and execute process validation activities (IQ/OQ/PQ)Ensure compliance with FDA regulations (21 CFR 820), ISO 13485, and GMP requirementsSupport audits and inspections (FDA, notified bodies, internal audits)Maintain manufacturing documentation in accordance with quality system requirementsEquipment & ToolingSpecify, qualify, and maintain manufacturing equipment and toolingCollaborate with suppliers on equipment design and installationTroubleshoot equipment and process issues to minimize downtimeCross-Functional CollaborationWork closely with Quality, R&D, Regulatory Affairs, Supply Chain, and Operations teamsSupport design for manufacturability (DFM) and design for assembly (DFA) effortsAssist in root cause investigations and corrective actions (CAPA)Continuous ImprovementApply Lean, Six Sigma, or other continuous improvement methodologiesDrive cost reduction, waste elimination, and efficiency improvementsAnalyze process data and implement corrective and preventive actionsRequired QualificationsEducationBachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related fieldExperience2-7 years of manufacturing engineering experience (level dependent)Experience in a regulated industry, preferably medical devicesHands-on experience with process validation and documentationTechnical SkillsKnowledge of FDA QSR, ISO 13485, GMPExperience with IQ/OQ/PQ validationINDTRAC