Manufacturing Engineer Medical Devices
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Job Location:
Plymouth, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- Bachelors 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
