Maintenance Technician

Compensation: $42.55 to $51.75 per hour (inclusive of $37.00 to $45.00 hourly base plus 15% shift premium for 3rd shift). Starting pay is based on relevant experience, skills, and qualifications. Candidates whose backgrounds more closely align with the position’s requirements and who bring greater directly related experience may be considered toward the upper end of the range.

Schedule: 3rd shift (10:00pm - 6:30am Sunday through Thursday)

Department: Processing

Reports To: Process Technician Supervisor

FLSA Status: Non-Exempt

Position Summary:

The Senior Process Technician serves as a technical expert in injection molding setup, troubleshooting, and process optimization. This position ensures molding processes operate within validated and documented parameters while supporting productivity, quality, and safety objectives in a regulated medical device manufacturing environment. The Senior Process Technician provides advanced technical support, leads troubleshooting efforts, assists with development samples when needed, and mentors Process Technicians I and II.

This role requires consistent compliance with ISO 13485, ISO 9001, cGMP, and all company Quality Management System (QMS) procedures.

Essential Duties and Responsibilities:

• Perform and verify setups as needed, including both routine and complex molding setups, ensuring adherence to approved parameters and work instructions.
• Assist and mentor Process Technician I and II employees during setups and startups, providing guidance and verification to ensure correct procedures are followed.
• Conduct startups for all production runs using validated parameters, including post-maintenance Tooling Work Order (TWO) runs, verifying that tooling repairs or adjustments have corrected the issue and that the process is stable before release to production.
• Troubleshoot complex molding, tooling, and equipment issues to determine root cause and implement corrective actions or escalate appropriately.
• Collaborate closely with Engineering, Quality, and Maintenance to resolve process deviations, nonconformances, and equipment-related issues.
• Review and verify accuracy of Standard Work Instructions (SWIs), Master Process Sheets, and process documentation; coordinate with Engineering or Document Control when corrections or updates are needed.
• Support development sampling and validation activities as assigned, assisting with setup, documentation, and process adjustments under Engineering or Process Development direction.
• Apply scientific molding principles and data-driven methods during troubleshooting and process improvement efforts.
• Ensure all process-related documentation is complete, accurate, and compliant with GDP and QMS standards.
• Write, review, and track Tooling Work Orders (TWOs) for tooling or process issues requiring maintenance or engineering attention.
• Verify that all relevant process and maintenance documentation is completed correctly by Process Technicians I and II.
• Support QMS initiatives including CAPA, NCR investigations, internal audit readiness, and continuous improvement documentation.
• Participate in or lead small-scale continuous improvement projects to enhance efficiency, product quality, or safety.
• Partner with Production Supervisors to ensure smooth shift transitions, effective communication, and adherence to production schedules.
• Demonstrate and enforce proper cleanroom and contamination control procedures in both cleanroom and general production areas.
• Other duties as assigned

Knowledge, Skills, and Abilities:

• Expert-level understanding of injection molding processes, tooling, materials, and auxiliary equipment.
• Strong knowledge of ISO 13485, ISO 9001, cGMP, and QMS documentation requirements.
• Proficiency in root-cause analysis and troubleshooting techniques.
• Ability to interpret process data, setup sheets, validation reports, and engineering drawings.
• Working knowledge of scientific molding principles, data collection, and process control.
• Demonstrated leadership, mentoring, and team collaboration skills.
• Strong attention to detail and accuracy in documentation and communication.
• Effective cross-functional collaboration with Engineering, Quality, and Production departments.
• Commitment to workplace safety, product quality, and regulatory compliance.

Education and Experience Requirements:

• High school diploma or equivalent required; associate or technical degree in plastics, manufacturing, or engineering technology preferred.
• 5 or more years of experience in injection molding, including process…