Bachelor's degree in mechanical or electrical engineering
2+ years hands-on engineering experience
Process development, validation, and optimization
The role focuses on ensuring efficiency, quality, and continuous improvement of manufacturing processes for high-quality medical devices
Job Summary
The role focuses on ensuring efficiency, quality, and continuous improvement of manufacturing processes for high-quality medical devices.
Candidates will collaborate with cross-functional teams to troubleshoot issues, develop test fixtures, and maintain compliance with FDA regulations.
The position requires developing comprehensive manufacturing documentation including pFMEA, control plans, and work instructions while driving cycle time reduction.
Matching Summary
The role focuses on ensuring efficiency, quality, and continuous improvement of manufacturing processes for high-quality medical devices.
Skills & Requirements
Must-have
Bachelor's Degree in Mechanical or Electrical Engineering
2+ years hands-on engineering experience
Process development, validation, and optimization
Regulated manufacturing environment knowledge
Test system development and fixture design
ISO requirements, FDA Regulations, and cGMPs
Electronic troubleshooting and soldering skills
Nice-to-have
Lean manufacturing and Six Sigma methodologies
LabVIEW and Minitab data analysis experience
Robotics or electro-mechanical product experience
IPC-A-610 and IPC-A-620 standards familiarity
Cross-functional team collaboration skills
Strong written communication for documentation
Supplier interaction and RMA process management
Key Requirements
Bachelor's Degree in Mechanical or Electrical Engineering
Minimum 2 years of hands-on engineering experience
Experience in a regulated manufacturing environment
Knowledge of ISO, FDA, and cGMP regulations
Proficiency in electronic troubleshooting and soldering