Ensure iso 13485 and fda 21 cfr part 820 compliance
The Project Engineer will oversee engineering projects specializing in contract manufacturing for medical devices from conception to completion
Job Summary
The Project Engineer will oversee engineering projects specializing in contract manufacturing for medical devices from conception to completion.
Responsibilities include planning assembly processes, ensuring regulatory compliance with ISO 13485 and FDA standards, and leading IQ/OQ/PQ activities.
The role requires strong technical skills and the ability to communicate with customers to provide excellent engineering solutions.
Matching Summary
The Project Engineer will oversee engineering projects specializing in contract manufacturing for medical devices from conception to completion.
Skills & Requirements
Must-have
Manage assembly processes of medical devices
Lead IQ OQ PQ qualification activities
Ensure ISO 13485 and FDA 21 CFR Part 820 compliance
Develop engineering documentation and quality plans
Coordinate cross-functional teams to resolve issues
Nice-to-have
Excellent project management skills demonstrated
Strong written and verbal English communication
Ability to interpret customer requirements effectively
Key Requirements
Bachelor's degree or Diploma in mechanical or electrical engineering
Minimum 2 years of experience in project coordination or management
Strong understanding of medical device regulations and standards