Injection Molding Manufacturing Engineer Co-Op

Micron Solutions; Fitchburg (MA); On-site; USD 33,000 - 36,000; Full time

Job summary

Micron Solutions in Fitchburg, MA is seeking an Injection Molding Manufacturing Engineer Co-op to support regulated medical device production. The role offers hands-on experience with injection molding, tooling, automation, and quality systems while ensuring FDA and ISO compliance.

The co-op runs from January 11, 2027 to May 28, 2027 and involves process development, fixture and EOAT design, validations (IQ/OQ/PQ), CAPA activities, and collaboration with Manufacturing, Quality, Tooling, and

Qualifications

• Pursuing a Bachelor's degree in Mechanical, Manufacturing, Plastics, or Biomedical Engineering.
• Strong interest in medical device manufacturing 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 be on-site Monday through Friday.

Responsibilities

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

Skills

Attention to detail

Strong communication

Microsoft Office

SolidWorks

Education

Bachelor's degree in Mechanical, Manufacturing, Plastics, or Biomedical Engineering

Tools

SolidWorks

Job description

Job Details

Job Location: fitchburg, MA 01420

Salary Range: $24.00 - $26.00 Hourly

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