Manufacturing Engineer II
Core
Develops robust, capable, cost-effective, and safe manufacturing processes, equipment, and materials to support the transfer of new products into commercial production.
Role type
Manufacturing Engineer II (Process & Equipment)
Builds
Manufacturing processes, equipment, tooling, and materials for commercial production
Domain
Medical technology manufacturing
Required skills
DFSS/DMAIC tools, Lean methodologies, process validation techniques, PFMEA, equipment calibration, process optimization, troubleshooting, technical documentation, regulatory compliance
Preferred skills
Mechanical, Chemical, or biomedical engineering background
Technologies
DFSS, DMAIC, Lean, PFMEA, Calibration Management Systems
Responsibilities
Support design, optimization, validation, and troubleshooting of process technologies; provide input to equipment engineering and vendors for new equipment/tooling selection and development; execute experimentation and testing to characterize and optimize processes; support introduction of new processes, equipment, and materials including installation, calibration, and EHS assessment; apply Lean methodologies to eliminate waste and improve efficiency; support process and equipment validation including writing validation documentation (FMEA, Validation Plans, protocols); ensure compliance with quality system regulations; perform equipment calibration services ensuring measurement traceability; develop technical engineering reports and calibration procedures; train technicians on calibration procedures; support budget development for calibration department.
Seniority
Mid-level, hands-on IC