Manufacturing Engineer

Intellectt Inc; Plano (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Intellectt Inc. in Plano, TX seeks a Sr. Manufacturing Engineer to provide technical leadership for manufacturing operations, focusing on troubleshooting, yield improvement, defect reduction, process optimization, and continuous improvement.

The role leads complex investigations, equipment validations, and cross-functional improvement projects in a regulated environment. You will mentor junior engineers, present findings to leadership, and ensure compliance with FDA, ISO and GMP standards while

Qualifications

• Bachelor's degree in Mechanical, Industrial, Electrical, Chemical, Bioengineering, or related field.
• 5+ years of Manufacturing Engineering experience in a regulated environment.
• Experience with process improvement, cross-functional projects, and validation activities.
• Strong root cause analysis and corrective action experience.

Responsibilities

• Lead troubleshooting of complex manufacturing, process, and equipment issues.
• Analyze yield, scrap, defect, and process data to identify improvement opportunities.
• Conduct root cause analysis using 6M, 5 Why, Fishbone, DOE, and statistical methods.
• Drive continuous improvement focused on quality, productivity, cost, and capacity.
• Lead cross-functional CAPA investigations and corrective actions.
• Plan and execute IQ/OQ/PQ equipment and process validations.
• Develop and optimize manufacturing processes, SOPs, work instructions, and control plans.
• Support automation, tooling, and process improvement initiatives.
• Mentor junior engineers and manufacturing personnel.
• Present technical findings, recommendations, and project status to leadership.
• Ensure compliance with FDA, ISO, GMP, and internal quality systems.

Skills

Troubleshooting

Yield improvement

Defect reduction

Process optimization

Continuous improvement

Root cause analysis

DOE

Statistical methods

CAPA investigations

Mentoring

Education

Bachelor's in Mechanical/Industrial/Electrical/Chemical/Bioengineering

Tools

Minitab

JMP

MES/ERP systems

Job description

The Sr. Manufacturing Engineer will provide technical leadership for manufacturing operations, focusing on troubleshooting, yield improvement, defect reduction, process optimization, and continuous improvement. The role will lead complex investigations, equipment/process validations, and cross-functional improvement projects while ensuring compliance with FDA, ISO, and GMP requirements.

Key Responsibilities

• Lead troubleshooting of complex manufacturing, process, and equipment issues.
• Analyze yield, scrap, defect, and process data to identify improvement opportunities.
• Conduct root cause analysis using 6M, 5 Why, Fishbone, DOE, and statistical methods.
• Drive continuous improvement focused on quality, productivity, cost, and capacity.
• Lead cross-functional CAPA investigations and corrective actions.
• Plan and execute IQ/OQ/PQ equipment and process validations.
• Develop and optimize manufacturing processes, SOPs, work instructions, and control plans.
• Support automation, tooling, and process improvement initiatives.
• Mentor junior engineers and manufacturing personnel.
• Present technical findings, recommendations, and project status to leadership.
• Ensure compliance with FDA, ISO, GMP, and internal quality systems.

Required Qualifications

• Bachelor's degree in Mechanical, Industrial, Electrical, Chemical, Bioengineering, or related Engineering discipline.
• 5+ years of Manufacturing Engineering experience, preferably in a regulated industry.
• Experience with manufacturing support, process improvement, and cross-functional projects.
• Experience with IQ/OQ/PQ validation.
• Strong root cause analysis and corrective action experience.
• Strong analytical, troubleshooting, communication, and problem-solving skills.

Preferred Qualifications

• Medical device, pharmaceutical, biotechnology, or regulated manufacturing experience.
• Lean Manufacturing / Six Sigma experience or certification.
• Experience with Minitab, JMP, or similar statistical tools.
• Automation, robotics, vision systems, or advanced manufacturing experience.
• MES/ERP and manufacturing data systems experience.
• DOE, process characterization, and validation experience.
• Experience mentoring engineers and technicians.