Manufacturing Process Engineer
Core
Design, implement, and maintain manufacturing processes for minimally invasive vascular devices, ensuring compliance with regulations and optimizing production flow.
Role type
Manufacturing Process Engineer
Builds
Medical device production lines and process specifications
Domain
Healthcare / Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development and optimization, Six Sigma, risk analysis, process characterization, process validation, scale-up, technology transfer, PFMECA, DFMECA, cGMP compliance, regulatory filings
Preferred skills
Experience with small drug molecules and polymers based drug delivery systems, late stage or commercial product manufacturing support
Technologies
Process flow sheets, instrumentation and control systems, processing equipment
Responsibilities
Calculate and organize data for complex process flow sheets, model processes and unit operations, prepare specifications and operating instructions for processing equipment, conduct tests and measurements to control variables like temperature and pressure, troubleshoot engineering problems with processes or equipment, ensure compliance with regulations, manage corrective and preventive actions
Seniority
Experienced, limited supervision