Senior Quality Engineer, NPI & Lifecycle (MedTech)

Johnson & Johnson Innovative Medicine; Irving (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson’s MedTech division in Irving, Texas, seeks a Senior Quality Engineer for New Product Innovation & Lifecycle Management (NPI/LCM) to ensure safe, effective medical devices through design control, risk management, and cross-functional collaboration. You will support product quality from concept through lifecycle, advancing state-of-the-art Aesthetics & Reconstruction products.

You will review development activities, risk assessments, and verification/validation plans to ensure

Qualifications

• Bachelor’s degree in engineering, science, or related technical field from an accredited university.
• Minimum of 5 years of work experience in a regulated industry.
• New product development and/or lifecycle management experience.
• Prior experience in a Quality Engineering role.
• Knowledge of FDA requirements for design control of medical devices.

Responsibilities

• Support product quality throughout lifecycle for NPI/LCM.
• Review design controls, verification/validation, and validation documents for conformance.
• Participate in risk management and CAPA in the QMS.
• Provide statistical support for product development and manufacturing.
• Mentor and guide engineers and collaborate with cross‑functional teams.

Skills

Quality engineering

Risk management

Regulatory compliance

Statistical methods

Cross-functional collaboration

Education

Bachelor’s degree in engineering or related field

Advanced degree (preferred)

Job description

Johnson & Johnson’s MedTech division in Irving, Texas, seeks a Senior Quality Engineer for New Product Innovation & Lifecycle Management (NPI/LCM) to ensure safe, effective medical devices through design control, risk management, and cross-functional collaboration. You will support product quality from concept through lifecycle, advancing state-of-the-art Aesthetics & Reconstruction products.

You will review development activities, risk assessments, and verification/validation plans to ensure