Medical Device Process Technician — 2nd/3rd Shift (ISO 13485)

Connexion Systems & Engineering Inc.; Leominster (MA); On-site; USD 37,000 - 48,000; Full time

Job summary

Connexion Systems & Engineering Inc. in Leominster, MA, seeks an experienced Medical Device Process Technician for 2nd and 3rd shifts to support regulated injection molding and automated assembly operations.

You will set up, troubleshoot, and maintain processes to ensure product quality in an ISO 13485 environment. The role emphasizes maintaining validated manufacturing processes, collaborating with Engineering and Quality on process validation activities, and driving continuous improvement to

Qualifications

• ,
• 3–5+ years hands-on injection molding processing experience.
• Experience in ISO 13485-regulated medical device manufacturing.
• Experience supporting robotics and automated assembly equipment.

Responsibilities

• Set up and start injection molding machines per production schedules and approved process parameters.
• Set up, maintain, and troubleshoot auxiliary equipment required for production.
• Troubleshoot molding machines, robotic systems, automated assembly equipment, and process-related issues to minimize downtime.
• Respond to machine alarms and make process adjustments as needed.
• Perform mold and job changeovers.
• Monitor machine performance, cycle times, process stability, and product quality throughout production.
• Support automated assembly operations, including vision systems, robotics, conveyors, and EOAT.
• Complete and maintain process setup sheets, process logs, and other required production documentation.
• Ensure line clearances are completed and documented at the end of production runs.
• Verify products meet quality requirements using measuring and inspection equipment.
• Enter and maintain accurate production information in the IQMS/ERP system.
• Generate and complete required production and scrap reports.
• Support validated manufacturing processes and maintain compliance with approved process parameters.
• Assist Engineering and Quality teams during process validation activities, including IQ/OQ/PQ.
• Monitor process capability and implement improvements to reduce variation and improve product quality.
• Support root-caused investigations and corrective action activities related to molding and automated assembly processes.
• Identify opportunities to reduce scrap, improve efficiency, improve process capability, and enhance product quality.
• Support Lean Manufacturing and continuous improvement initiatives.
• Collaborate with Engineering and Quality teams on process improvements, validation activities, corrective actions, and new product introductions.
• Maintain compliance with ISO 13485 requirements and medical device manufacturing standards.
• Support customer audits, vendor visits, and regulatory inspections as needed.
• Follow all company safety policies and maintain a clean, organized, and safe work environment.
• Perform other duties as assigned.

Skills

Injection molding

Robotics

Automation equipment

Documentation

Process troubleshooting

Education

High School Diploma or GED

Tools

IQMS/ERP

DELMIAWorks

Job description

Connexion Systems & Engineering Inc. in Leominster, MA, seeks an experienced Medical Device Process Technician for 2nd and 3rd shifts to support regulated injection molding and automated assembly operations.

You will set up, troubleshoot, and maintain processes to ensure product quality in an ISO 13485 environment. The role emphasizes maintaining validated manufacturing processes, collaborating with Engineering and Quality on process validation activities, and driving continuous improvement to