Manufacturing Engineer (2nd Shift)
Core
Manufacturing Engineer supporting production lines and molding processes for Liquid Silicone Rubber (LSR) medical devices.
Role type
Manufacturing Engineer (LSR Molding)
Builds
Medical device components via LSR molding
Domain
Medical device manufacturing / LSR molding
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process optimization, Root cause analysis, Validation protocols (IQ/OQ/PQ), Control plan development, CAD design (SolidWorks), Data analysis (Minitab/JMP), Regulatory compliance (ISO 13485/FDA), Cross-functional collaboration
Preferred skills
Six Sigma Green Belt, PMP certification, Process monitoring systems (RJG/Kistler), Master's degree in engineering
Technologies
SolidWorks, Minitab, JMP, RJG, Kistler
Responsibilities
Validate robust manufacturing processes for LSR molding, Lead process improvement initiatives to enhance productivity, Serve as technical lead in root cause investigations, Ensure compliance with ISO 13485 and FDA regulations, Coordinate with vendors for equipment selection and commissioning, Research and integrate emerging technologies in LSR molding
Seniority
Mid-level, hands-on IC