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

Stark Pharma

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