Job Description

Job Title: Manufacturing Engineer Medical Devices

Location: Plymouth, MN & Irvine, CA & Boston, MA

Job Summary

We are seeking a Manufacturing Engineer to support production processes in a regulated medical device environment. This role focuses on improving manufacturing efficiency, ensuring product quality, and supporting new product introduction while maintaining compliance with industry standards.

Key Responsibilities

• Develop, implement, and optimize manufacturing processes for medical devices
• Support production activities, troubleshooting issues and improving yield
• Assist with new product introduction (NPI) and process transfer to manufacturing
• Create and maintain work instructions, SOPs, and process documentation
• Collaborate with Quality, R&D, and Operations teams to ensure compliance and performance
• Support process validation activities (IQ/OQ/PQ)
• Drive continuous improvement initiatives (Lean, Six Sigma)
• Ensure compliance with FDA, ISO 13485, and GMP requirements

Required Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related field)
• 2 5 years of experience in medical device manufacturing or regulated industry
• Knowledge of manufacturing processes and quality systems
• Understanding of FDA regulations and ISO 13485 standards
• Strong problem-solving and analytical skills

Job Tags

Similar Jobs