Manufacturing Engineer – Medical Device Production

About the role

We are looking for a detail‑oriented Manufacturing Engineer to join our fast‑paced medical device operation in Lakewood, IL. The role focuses on improving processes, supporting production, and ensuring compliance with FDA and ISO standards.

Key responsibilities

• Develop, optimize, and maintain manufacturing processes for medical device production.
• Support process validation activities, including IQ, OQ, and PQ protocol execution.
• Collaborate with Quality, R&D, Regulatory Affairs, and Production teams.
• Analyze manufacturing data to identify cost‑reduction and efficiency opportunities.
• Troubleshoot equipment and process issues on the production floor.
• Create and maintain SOPs, work instructions, BOMs, and process flow diagrams.
• Assist in equipment qualification, calibration, and preventive maintenance.
• Ensure compliance with FDA regulations, GMP, ISO 13485, and internal quality standards.
• Participate in CAPA investigations, root‑cause analysis, and corrective actions.
• Support new product introduction and transfer from development to manufacturing.

Required profile

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

Required skills

• Process validation (IQ, OQ, PQ)
• Good Manufacturing Practice (GMP)
• FDA regulatory compliance
• Lean Manufacturing
• Six Sigma
• Equipment qualification and calibration
• Preventive maintenance planning
• SOP and work instruction development
• BOM management
• Process flow diagram creation