Plastics Injection Molding – Manufacturing Engineer II

Overview

Life Unlimited. At Smith+We design and manufacture technology that takes the limits off living. The Plastics Engineer II will serve as a primary technical resource on the manufacturing floor, focusing on hands‑on injection molding processing and mold maintenance to support medical device production. This position is not offering any type of visa transfer or sponsorship now or in the future.

• Lead injection molding process development and optimization using scientific molding techniques (e.g., DOE, viscosity curves, cavity pressure monitoring) to ensure consistent quality and efficiency.
• Perform and manage mold preventative maintenance (PM), repair, and modification to maximize mold life and minimize downtime.
• Act as the technical lead in resolving production issues related to machinery, tooling, materials, and process deviations.
• Develop and execute validations (IQ/OQ/PQ) for new molds, processes, and equipment in compliance with FDA and ISO
  13485 regulations.
• Lead mold trials, machine setups, and commissioning of new molds/equipment.
• Maintain meticulous process documentation, including Process Flow Diagrams, Mold Maintenance Logs, and Work Instructions.
• Collaborate with Product Development on Design for Manufacturability (DFM) and support the tooling team with CAD reviews and mold flow analysis.

• Bachelor’s degree in Plastics Engineering.
• 2+years of hands‑on experience in plastic injection molding, specifically within the medical device or high‑precision industry.
• Deep understanding of scientific molding processes.
• Strong mold maintenance, tooling, and repair capabilities (e.g., hot runners, mold disassembly).
• Proficiency in CAD software (Solid Works or AutoCAD).
• Experience with medical regulatory requirements (GMP/ISO
  13485).
• Ability to lift 35lbs.
• Travel requirements: