Plastics Engineer - Medical Device Manufacturing W2 ONLY

**Job Title Plastics Engineer Medical Device Manufacturing

Job Location Type In person

Location**

Indianapolis, IN 46268

Job Type 12 months with possibility of extension

About The Role

We are seeking a hands-on Plastics Engineer with strong expertise in injection molding, plastics tooling, and medical device manufacturing within a regulated environment. This individual contributor role will support the development, validation, and optimization of plastic components and manufacturing processes while collaborating closely with cross-functional teams including R\&D, Quality, Manufacturing, and Supply Chain. The ideal candidate will possess strong technical knowledge in scientific molding, process development, troubleshooting, and manufacturing process improvement.

Key Responsibilities

Lead and support plastics engineering projects related to the design, development, and manufacturing of medical device components

Develop, validate, and optimize injection molding processes to improve quality, efficiency, and product performance

Support tooling development, mold qualification, and manufacturing process validation activities

Participate in mold and part design reviews to ensure manufacturability and process capability

Conduct Data-driven Analysis Using

• Design of Experiments (DOE)
• Statistical Process Control (SPC)
• Failure Mode and Effects Analysis (FMEA)
• Mold Flow Analysis

Troubleshoot molding, tooling, and material-related issues and implement corrective actions

Collaborate with R\&D, Quality, Manufacturing, and Supply Chain teams to resolve technical and production challenges

Generate And Maintain Engineering Documentation Including

• Process validation documentation
• Engineering change documentation
• Risk assessments
• Process development reports

Ensure compliance with applicable quality standards and validation requirements within a regulated manufacturing environment

Identify opportunities for process optimization, scrap reduction, cost savings, and continuous improvement using Lean Manufacturing principles

Provide technical support during new product introduction (NPI), process transfers, and manufacturing scale-up activities

Required Qualifications

Bachelor s degree in Mechanical Engineering, Plastics Engineering, Manufacturing Engineering, or related field

Minimum 5 years of experience in plastics tooling and manufacturing processes

Hands-on experience with injection molding and plastics processing in a manufacturing environment

Previous Experience Within The Medical Device Industry Required

Experience supporting validation activities and regulated manufacturing processes

Strong understanding of Scientific Molding and process development methodologies

Knowledge of the complete injection molding cycle from mold close through mold open

Experience With

• DOE
• SPC
• FMEA
• Mold Flow Analysis

Proficiency with SolidWorks, GD\&T, and Minitab or similar statistical analysis software

Knowledge of polymer material properties and molding behavior; polyolefins experience preferred

Experience with Lean Manufacturing and continuous improvement methodologies

Proven project management experience with the ability to manage technical initiatives from development through production

Strong troubleshooting, analytical, and problem-solving skills

Excellent technical documentation and communication skills

Preferred Qualifications

Experience supporting new product introduction (NPI) activities

Experience with tooling development and mold qualification processes

Familiarity with regulated manufacturing environments and validation documentation practices

Ability to work effectively in cross-functional teams within fast-paced manufacturing environments

Strong technical leadership and hands-on shop floor support experience