Molding Process Engineer
On-site · Tamarac, Florida, United States
Job Summary
Molding Process Engineer in ENNOVI Medical will develop, validate, and optimize injection molding processes for new and existing medical products, lead root cause analyses and corrective actions for molding-related defects, and ensure compliance with GMP, ISO 13485, and FDA requirements. The role includes qualifying molds (IQ/OQ/PQ), monitoring process data for continuous improvement, implementing process controls to enhance molding performance, training operators and technicians, and collaborating with tooling, quality, and production teams on new product introductions and engineering changes. Requires a Bachelor’s degree in Mechanical/Industrial/Plastics Engineering (or equivalent) with at least 3 years of plastics/polymer processing experience; strong data analysis, problem-solving, and communication skills; experience in manufacturing medical devices; and preferred Six Sigma Greenbelt, insert molding, RJG Master Molder certification, automation/robotics, and ERP/MES familiarity.
Required Qualifications
- Bachelor’s degree in Mechanical, Industrial, or Plastics Engineering or equivalent (5 years in relevant experience)
- Minimum of 3 years of experience within a Plastics/Polymer processing
- Strong understanding of Polymer technology and test methods
- Experience and proficient with: Data Analysis, Root Cause Analysis, Statistical Method Application, Process Validations
- Experience with functioning in a highly regulated environment
- Strong written and verbal communication skills
- Demonstrate problem solving skills
- Demonstrated experience in manufacturing medical devices using various manufacturing technologies
- Excellent process development capabilities
- Preferred Skills: Six Sigma Greenbelt and Lean Process Background
- Experience working with insert molding
- RJG Master Molder certification or equivalent
- Experience with automation and robotics in molding operations
- Familiarity with ERP and MES systems
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