Position Summary:

The Process Technician I is responsible for supporting injection molding operations by performing machine setups, routine startups, and shutdowns under supervision. This position plays a key role in ensuring molding processes are executed according to established parameters and documentation. The Process Technician I follows all Good Documentation Practices (GDP) and Quality Management System (QMS) procedures within a regulated medical device manufacturing environment.

Schedule: Friday - Sunday, 6:00 p.m. - 6:30 a.m. *Includes 16.5% shift differential

Essential Duties and Responsibilities:

Perform machine and work cell setups in accordance with approved setup sheets and instructions.
Conduct startups for routine molding processes, ensuring parameters match validated settings.
Perform proper machine shutdowns, including purging, material changes, and completion of end-of-run documentation.
Verify work cell readiness and perform daily work cell verifications.
Accurately complete all required production and process documentation to support traceability within the QMS.
Follow all ISO 13485, ISO 9001, and cGMP standards in daily activities.
Submit maintenance requests and communicate equipment issues to the Process Technician Supervisor.
Communicate with Material Handlers to coordinate material changes and next runs.
Follow established safety, quality, and cleanroom protocols.
Participate in smaller-scale continuous improvement projects by presenting ideas and solutions.
Write Tooling Work Orders (TWOs) to document mold, setup, or process-related issues requiring tooling or engineering attention.
Rotate through the tool room to gain understanding of mold design, function, and basic maintenance for improved troubleshooting communication.
Other duties as assigned.

Knowledge, Skills, and Abilities:

Basic understanding of injection molding machines, tools, and auxiliary equipment.
Awareness of QMS principles and regulatory expectations in medical device manufacturing.
Understanding of Good Documentation Practices (GDP).
Strong attention to detail and ability to follow technical instructions.
Team-oriented with effective communication and collaboration skills.
Basic problem-solving ability with willingness to learn and grow.
Ability to work efficiently in both cleanroom and general production environments while following all safety and contamination control procedures.

Education and Experience Requirements:

High school diploma or equivalent required.
Technical certificate or coursework in manufacturing, plastics, or related field preferred.
1–2 years of experience in a plastics environment preferred.
Completion of Paulson Molding I required (may be completed during initial training period if nor previously certified).
Completion of Paulson Molding II required as pre-requisite to Process Technician II.

Physical Requirements:

Ability to stand and walk for extended periods throughout the shift (up to 12 hours).
Frequent bending, reaching, twisting, and lifting of objects up to 50 lbs independently.
Ability to perform transport, installation, and alignment of molds, tooling, and auxiliary equipment that may weigh several hundred to several thousand pounds using forklifts, overhead hoists/cranes, and other approved lifting devices.
Safely operate a forklift, pallet jacks, hoists/overhead cranes, and other material-handling equipment (training and certification performed onsite).
Requires manual dexterity for working with small parts, tools, and precision instruments.
Ability to work in both cleanroom and general production environments while wearing required PPE and following contamination control and safety procedures.
Visual acuity sufficient to inspect molded parts and read gauges, indicators, and digital displays.
Ability to work in hot, noisy, or confined areas during machine setup or maintenance activities.

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Setup Technician