What are the responsibilities and job description for the Process Engineer position at ITMC Systems, Inc?
Required Skills
- 5 years of Process Engineering experience
- Medical Device or Pharmaceutical Manufacturing background
- Manufacturing Process Development & Optimization
- Process Validation (IQ/OQ/PQ)
- Equipment Qualification & Installation
- Statistical Process Control (SPC)
- Statistical Data Analysis (Minitab preferred)
- Yield Improvement & Continuous Improvement
- Root Cause Analysis (RCA) & CAPA
- Design Transfer / New Product Introduction (NPI)
- Experience working with R&D, Quality, Manufacturing & Operations
- Knowledge of FDA, GMP, ISO 13485 regulated environments
- Strong documentation and technical communication skills