Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Minnetonka, MN

Duration: Long Term

Job Summary

We are seeking a detail-oriented and motivated Manufacturing Engineer to support manufacturing operations within a fast-paced medical device environment. The ideal candidate will be responsible for improving manufacturing processes, supporting production activities, implementing continuous improvement initiatives, 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/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.
• Assist in equipment qualification, calibration, and preventive maintenance activities.
• 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.
  
  

Required Qualifications

• 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.