The Molding Engineer is responsible for leading several aspects of plastic molding oversight for the business. This includes working with Tooling Engineers and suppliers to optimize precision injection molding processes to produce high-quality plastic components with tight tolerances. This role involves hands-on engineering, process validation, troubleshooting, and collaboration with cross-functional teams to ensure efficient and reliable manufacturing operations.

The Molding Engineer is also responsible for the molding activities to attain strategic engineering objectives for the Business Unit. Works regularly with R&D, operations, supply chain, quality and suppliers. Performs capacity analysis for molds, injection molding machines and makes recommendations for future investment. Manages measurement system analysis, design control and executing equipment selection, process development, validation, FMEA and Design of Experiments (DOEs).

What You’ll Work On

• Ensure compliance with country regulations and ISO standards while driving innovation and efficiency in manufacturing.
• Drive continuous improvement in overall mold lifecycle management by implementing a robust system for measuring tool life and planning for future investments.
• Partner with extended team members in R&D, manufacturing quality and suppliers to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
• Define molding process windows by applying Scientific Molding methodologies utilizing design of experiment (DOE) tools and software.
• Develop the relationship between molding key process input variables (KPIVs) and key process output variables (KPOVs) for plastic components throughout the value stream.
• Work with suppliers to specify critical molding cell equipment from mold, molding machines, end of arm tooling, machine side automation, and assembly operations.
• Oversee the writing of specifications; design verification/validation (IQ, OQ and PQ) protocols and reports.
• Lead Factory Acceptance Testing (FAT) at equipment manufacturers for acceptance per company equipment URS and mold build standards
• Lead cross-functional teams to investigate and resolve molding issues.
• Apply knowledge of SOLIDWORKS CAD design software and the ability to develop sophisticated 3D models and flow modeling.
• Apply process design and development expertise along with knowledge of tooling/automation design and procurement/qualification of new molds.
• Ensures compliance with Environmental, Safety, Quality and Compliance expectations of the business.

Required Qualifications

• Bachelor’s Degree in an Engineering or technical discipline such as Plastics Engineering, Mechanical Engineering, Materials Science, Polymer Science, Industrial Engineering, etc.
• 5-10 years of technical work experience in precision injection molding, preferably in the medical device industry.
• Knowledge of mold design fundamentals, molding process development, plastic resin behavior and required tooling/equipment.

Preferred Qualifications

• AIM Institute or equivalent certificate preferred.
• Knowledge of FDA QSR's and ISO requirements preferred.