Job Overview

The Manufacturing Technician V is the highest-level technical contributor within the Manufacturing Technician career path. This role serves as the primary technical resource for sustaining manufacturing operations, providing advanced troubleshooting, process support, equipment oversight, validation execution, calibration coordination, and technical leadership on the production floor.The position is responsible for maintaining process stability, supporting manufacturing performance, driving corrective actions, and ensuring compliance with quality and regulatory requirements. The Manufacturing Technician V partners closely with Manufacturing Engineering, Quality, Operations, Maintenance, and Supply Chain to ensure safe, efficient, and compliant manufacturing processes.

Job Requirements

Technical Leadership
Serve as the technical lead and Subject Matter Expert (SME) for assigned manufacturing processes and equipment.
Provide technical guidance and mentoring to technicians and operators.
Support Manufacturing Engineers in implementing process improvements and corrective actions.
Lead technical problem-solving activities and drive resolution of complex manufacturing issues.
Production Floor Support
Provide daily hands-on support to manufacturing operations to maintain process stability and product quality.
Monitor process performance, yield, scrap, downtime, and quality metrics.
Identify process deviations and implement containment and corrective actions.
Support production in meeting safety, quality, delivery, and productivity objectives.
Advanced Problem Solving
Lead investigations related to non-conformances, process deviations, customer complaints, equipment failures, and CAPA activities.
Conduct root cause analysis using structured methodologies such as 5 Why's, Fishbone, DMAIC, and statistical analysis tools.
Implement, document, and verify effectiveness of corrective and preventive actions.
Drive continuous improvement initiatives focused on process robustness and operational excellence.
Validation & Documentation
Execute and document process validations, equipment qualifications, revalidations, engineering studies, and process characterizations.
Support protocol execution, data collection, analysis, and report generation.
Ensure compliance with GDP, GMP, FDA, ISO 13485, and internal quality requirements.
Maintain technical documentation including procedures, work instructions, forms, equipment records, and validation files.
Calibration & Equipment Support
Coordinate calibration activities for manufacturing and inspection equipment.
Ensure equipment remains in a calibrated and validated state.
Support equipment troubleshooting, preventive maintenance, and qualification activities.
Assist in equipment installation, commissioning, and validation activities.
Continuous Improvement
Identify opportunities to improve yield, reduce scrap, improve cycle times, and increase process capability.
Participate in Lean Manufacturing and continuous improvement projects.
Support implementation of poka-yokes, process controls, and standardization initiatives.
Utilize data analysis to support decision-making and process optimization.
Critical Competencies
Advanced Problem Solving & Root Cause Analysis.
Technical Leadership.
Manufacturing Process Expertise.
Validation & Qualification Execution.
Documentation & Compliance.
Floor Support & Process Monitoring.
Equipment Troubleshooting.
Calibration Management.
Data Analysis.
Continuous Improvement Mindset.
Cross-Functional Collaboration.
Decision Making & Prioritization.

What your background should look like

Experience 

• 1-2 years of working experience in the Medical Device Industry
• Experience with design controls FDA regulation, GMP practices, and QSR requirements.
• Experience in technically leading a team of engineers and technicians across multiple projects. 

Education 

• Bachelor’s degree in engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred.  
• MS Office Proficiency 
   

Professional Training & Certifications 

• Green Belt (Desirable)
• CAD Proficiency – SolidWorks and Mastercam 
   

Competencies