Manufacturing Engineer

About the role

We are seeking a detail-oriented and motivated Manufacturing Engineer to support manufacturing operations within a fast-paced medical device environment.

Responsibilities

• Develop, optimize, and maintain manufacturing processes for medical device production.
• Support process validation activities including IQ/OQ/PQ protocols and execution.
• Collaborate with cross-functional teams including Quality, R&D, Regulatory Affairs, and Production.
• Analyze manufacturing data and identify opportunities for process improvements, cost reduction, and increased efficiency.
• Troubleshoot equipment and process-related issues on the production floor.
• Create and maintain manufacturing documentation such as SOPs, work instructions, BOMs, and process flow diagrams.
• Absolutely ensure compliance with FDA regulations, GMP, ISO 13485, and company quality standards.
• Participate in CAPA investigations, root cause analysis, and implementation of corrective actions.
• Support new product introduction (NPI) and transfer from development to manufacturing.

Requirements

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field.
• 2-5 years of manufacturing engineering experience within the medical device or regulated industry.
• Experience with process validation (IQ/OQ/PQ), GMP, and FDA regulations.
• Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
• Strong problem-solving and analytical skills.
• Excellent communication and documentation abilities.