What are the responsibilities and job description for the Manufacturing Engineer - Medical Devices position at Stark Pharma?
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
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
- 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