Manufacturing Process Engineer
Core
Design, implement, and maintain manufacturing processes for medical device production, ensuring compliance with regulations and optimizing process flow.
Role type
Manufacturing Process Engineer
Builds
Medical device production lines and processes
Domain
Healthcare / Medical Devices / Manufacturing Engineering
Required skills
Process development and optimization, Six Sigma, risk analysis, process characterization, process validation, process monitoring, scale-up, technology transfer, PFMECA, DFMECA, Quality systems, cGMPs, regulatory filings, equipment troubleshooting, data analysis for process flow sheets, modeling of unit operations
Preferred skills
Experience with small drug molecules and polymers based drug delivery systems, late stage or commercial product manufacturing support
Technologies
Six Sigma, PFMECA, DFMECA
Responsibilities
Calculate and organize data for complex process flow sheets including instrumentation and control considerations, model processes and unit operations, ensure proper sequence of operation and prepare specifications and operating instructions for processing equipment, conduct tests and measurements throughout stages of production to determine control over variables such as temperature, density, pressure and viscosity, service, troubleshoot, and solve engineering problems with processes or equipment already in operation, ensure processes and procedures are in compliance with regulations, manage corrective and preventive actions and investigation management
Seniority
Mid-level, hands-on IC