Medical Device Process Technician

The successful candidate will play a critical role in maintaining validated manufacturing processes, optimizing production performance, supporting automation systems, and ensuring product quality for our medical device components and assemblies. This position supports production operations by monitoring equipment, resolving process issues, maintaining documentation, supporting validated manufacturing processes, and contributing to continuous improvement efforts.

Job Title: Medical Device Process Technician
Pay Rate: 2^nd Shift, $27.00-$34.00/hr. | 3^rd Shift $27.00-$35.00/hr.
Location: Leominster, MA 
Duration: Temp-Perm
Shift: Monday-Friday, 2^nd Shift 3:00pm - 11:00pm | 3^rd Shift 11pm-7:00am

Overview:
Seeking an experienced 2nd & 3^rd Shift Medical Device Process Technician to support our highly regulated injection molding and automated assembly operations.
This position is ideal for a skilled process technician with experience in medical device manufacturing, ISO 13485-regulated environments, robotics, and automated assembly systems. The successful candidate will play a critical role in maintaining validated manufacturing processes, optimizing production performance, supporting automation systems, and ensuring product quality for our medical device components and assemblies.
If you enjoy troubleshooting complex molding processes, working with advanced automation technology, and supporting manufacturing excellence in a regulated environment, we encourage you to apply.
What We're Looking For:
To be successful in this role, candidates should have:

• 3-5+ years of hands-on injection molding processing experience
• Medical device manufacturing experience
• Experience working in an ISO 13485-regulated environment
• Experience supporting robotics and automated assembly equipment
• Strong troubleshooting skills in molding, automation, and process control
• Experience maintaining validated manufacturing processes
• Ability to support quality, compliance, and continuous improvement initiatives

Job Summary:
The Medical Device Process Technician is responsible for setting up, troubleshooting, and maintaining injection molding processes to ensure products are manufactured safely, efficiently, and according to quality requirements. This position supports production operations by monitoring equipment, resolving process issues, maintaining documentation, supporting validated manufacturing processes, and contributing to continuous improvement efforts.
Key Responsibilities:

• Set up and start injection molding machines according to 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 end-of-arm tooling (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 cause 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.

Required Qualifications:

• High School Diploma or GED required.
• 3-5+ years of hands-on injection molding processing experience.
• Medical device manufacturing experience required.
• Experience working in an ISO 13485-regulated environment required.
• Experience supporting robotic automation systems and automated assembly equipment required.
• Strong troubleshooting skills involving molding machines, robots, automation equipment, and auxiliary systems.
• Ability to read and interpret engineering drawings, work instructions, and manufacturing documentation.
• Experience using dimensional inspection equipment and quality measurement tools.
• Proficiency with ERP/MRP systems and manufacturing software.
• Strong verbal and written communication skills.
• Ability to work independently while supporting production priorities.
• Ability to work 2nd shift.

Preferred Qualifications:

• Associate’s degree or technical training in Plastics Technology, Engineering, Manufacturing, or a related field.
• Experience with six-axis robots, Cartesian robots, vision systems, EOAT, and automated assembly cells.
• RJG Master Molder Certification or equivalent processing certification.
• Experience with IQMS or DELMIAWorks.
• Knowledge of process validation, DOE, scientific molding, and root cause analysis methodologies.
• Experience supporting high-volume medical device components and assembly operations.
• Understanding of Lean Manufacturing, 5S, and continuous improvement principles.