Injection Molding Manufacturing Engineer Co-Op fitchburg, MA 01420 Injection Molding Manufacturing Engineer Co-op 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 May 28, 2027 . 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