Senior Manufacturing Engineer, MedTech Ops & Process Improvement

6182-Mentor Texas LP Legal Entity; Irving (TX); On-site; USD 85,000 - 125,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Senior Manufacturing Engineer in Irving, TX. You will lead capital equipment installations, perform DOE and validations, and drive process improvements to optimize OEE and product quality. You will collaborate across functions, manage CAPA, and support GMP audits to ensure regulatory compliance.

The role requires a engineering degree and 4–6 years in a regulated environment, with strong project leadership and analytical skills.

Qualifications

• Bachelor's degree in Electrical, Mechanical, Chemical, Biomedical, or related Engineering discipline is required.
• 4–6 years of engineering experience in a regulated manufacturing environment is preferred.
• Experience leading capital equipment installation projects and knowledge of GMP/ISO standards.

Responsibilities

• Lead capital equipment installation projects with IQ/OQ/PQ activities and regulatory alignment.
• Design, execute, and document DOE studies and validation protocols.
• Develop and maintain production standards, work instructions, and procedures.
• Improve OEE and overall manufacturing performance through data-driven methods.
• Analyze manufacturing data for trend identification and process optimization.
• Manage moderate-to-high complexity engineering projects and CAPA activities.
• Support GMP audits and ensure data integrity and regulatory compliance.

Skills

Root Cause Analysis

FMEA

CAPA

NCR

Continuous Improvement

Project Management

Cross-functional Leadership

Communication Skills

Problem Solving

Statistics

Education

Engineering degree

Tools

MS Project

AutoCAD

SolidWorks

SCADA

Job description

Johnson & Johnson MedTech seeks a Senior Manufacturing Engineer in Irving, TX. You will lead capital equipment installations, perform DOE and validations, and drive process improvements to optimize OEE and product quality. You will collaborate across functions, manage CAPA, and support GMP audits to ensure regulatory compliance.

The role requires a engineering degree and 4–6 years in a regulated environment, with strong project leadership and analytical skills.