Injection Molding Manufacturing Engineer Co-Op

Job Details: Job Location: 25 Sawyer Passway - fitchburg, MA, Salary Range: $24.00 - $26.00Hourly, The Injection Molding Manufacturing Engineer Co-op will support manufacturing engineering activities within a regulated medical device manufacturing environment. This role provides hands-on experience in injection molding, automation, tooling, and quality systems while ensuring compliance with FDA regulations and ISO standards.

The co-op will assist with process development, fixture and end-of-arm tooling (EOAT) design, documentation, validation activities, and continuous improvement initiatives that support the safe, efficient, and compliant production of medical devices.

This co-op assignment will begin on January 11, 2027, and conclude on July 9, 2026.

Key Responsibilities

Support injection molding process setup, optimization, and troubleshooting in a regulated production environment
Assist in developing and maintaining controlled manufacturing documentation, including work instructions, process parameters, control plans, and risk assessments
Participate in root cause analysis, nonconformance investigations, and CAPA activities
Support process validations (IQ/OQ/PQ) in accordance with FDA and ISO 13485 requirements
Assist with new product introductions (NPI), tooling qualifications, and engineering change activities
Support the design and development of manufacturing fixtures and EOAT (End-of-Arm Tooling)
Create and revise CAD models and drawings using SolidWorks or similar CAD software
Collaborate with Manufacturing, Quality, Tooling, Automation, and Maintenance teams
Support Lean and continuous improvement initiatives while maintaining quality system compliance

Qualifications:
Currently pursuing a Bachelor’s degree in Mechanical, Manufacturing, Plastics, or Biomedical Engineering (or related field)
Strong interest in medical device manufacturing, injection molding, and automation
Attention to detail and ability to work within controlled, documented processes
Strong written and verbal communication skills
Proficiency in Microsoft Office (Excel, Word, PowerPoint)
Must have availability to work on-site Monday through Friday

Preferred Skills

Experience with SolidWorks or similar CAD software
Exposure to fixture design, EOAT design, or manufacturing automation
Familiarity with FDA 21 CFR 820, ISO 13485, or validation concepts
Lean Manufacturing or Six Sigma exposure