1st Shift Medical Device Process Technician at Micron Solutions in fitchburg, MA 01420

Job description

• Overview
• Micron Solutions is seeking an experienced 1st 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.
• 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
• 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.

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.

Requirements

• 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 1st Shift
• 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 component and assembly operations.
• Understanding of Lean Manufacturing, 5S, and continuous improvement principles.

Skills

Required

• Injection molding processing
• Medical device manufacturing
• ISO 13485-regulated environment
• Verbal and written communication
• Independent work
• 1st shift availability

Preferred

• IQMS or DELMIAWorks

Benefits

• At Micron Solutions, we recognize that our employees are critical to our success. We offer a competitive compensation and benefits package designed to support your health, financial well-being, and career growth.
• Competitive pay of $27.00 - $33.00 per hour
• Overtime opportunities available
• Comprehensive medical, dental, and vision insurance
• 401(k) with company match
• Company-paid life insurance
• Tuition Reimbursement Program
• Flexible Spending Accounts (FSA)
• Paid vacation, sick time, and company holidays
• Employee Assistance Program (EAP)
• Employee referral bonus program
• Modern, clean manufacturing environment
• Work with advanced injection molding, robotics, automation, and medical device manufacturing technologies
• Collaborative team culture focused on safety, innovation, and continuous improvement
• Stable company with a strong reputation in medical device and precision manufacturing
• $27.00 - $33.00 Hourly