Manufacturing Engineer (Medical Devices)

Location: Columbia Heights, Minnesota, United States

Company

hirify.global is an IT staffing and services company providing staff augmentation, talent management, permanent placement, and vendor management services to Fortune 500 and mid-size organizations.

What you will do

• Provide daily hands-on engineering support and troubleshooting for manufacturing lines producing Class III long-term implantable medical devices.
• Support processes including silicone rubber molding, crimping, resistance and laser welding, adhesive application, cutting, flushing, curing, inspection, and testing.
• Perform equipment installation, manufacturing process characterization, IQ/OQ/PQ activities, software validation, and test method validation.
• Prepare engineering analysis and documentation for material disposition, process updates, qualification activities, compliance activities, and CAPAs.
• Coordinate with calibration and maintenance groups to ensure equipment maintenance and calibration are completed on time.
• Support manufacturing facility and product transfer activities to offshore facilities and develop practical technical solutions to complex problems.

Requirements

• Bachelor’s degree in Engineering.
• At least five years of engineering experience in the medical device field.
• Experience with manufacturing process qualification, including IQ/OQ/PQ, software validation, and test method validation.
• Experience with FDA Quality System Regulation and ISO 13485 requirements.
• Understanding of applicable quality policies and quality-system procedures, with required training completed on time.

Nice to have

• Experience manufacturing Class III medical devices.

Culture & Benefits

• Contract engagement supporting medical device manufacturing operations.
• Collaboration with manufacturing, calibration, maintenance, and quality groups.
• Exposure to facility and product transfers involving offshore manufacturing sites.