MedTech Senior Quality Engineer: Failure Analysis Lead

Becton, Dickinson and Company; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Health & well-being

Retirement plan

Work-life balance

Leave programs

Job summary

Becton, Dickinson and Company (BD) is seeking a Senior Quality Engineer in Irvine, CA to lead failure analysis investigations on returned products, complaints, and nonconformances. You will apply structured problem-solving methods and collaborate across functions to identify root causes and drive CAPA implementations.

The role requires a strong background in medical device regulations (FDA 21 CFR Part 820, ISO 13485) and hands-on experience with analytical techniques.

Qualifications

• Bachelor's degree in Engineering or related field; Master's preferred.
• Minimum of 5 years in quality engineering with failure analysis in medical devices.
• Proven expertise in FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, DPA, X-ray.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, MDR.
• Ability to lead complex investigations and communicate data-driven conclusions.
• Excellent written and verbal communication; capable of presenting to diverse audiences.

Responsibilities

• Lead failure analysis investigations on returned products and complaints.
• Perform root cause analysis using 8D, 5-Why, Fishbone, FTA, and FMEA.
• Develop investigation plans and validate root causes.
• Use lab equipment and analytical tools to evaluate failures.
• Author technical reports communicating methods, findings, and recommendations.
• Support CAPA, corrective actions, and regulatory inquiries.
• Analyze product, manufacturing, reliability, and field data for improvements.
• Contribute to risk management and design FMEA activities.
• Support design verification, validation, and product robustness assessments.

Skills

Quality engineering

Failure analysis

FMEA

CAPA

Statistical analysis

8D

Ishikawa

microscopy

ISO 13485

FDA 21 CFR Part 820

Six-Sigma Black Belt

ASQ CQE/CRE

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

Statistical analysis software

Job description

Becton, Dickinson and Company (BD) is seeking a Senior Quality Engineer in Irvine, CA to lead failure analysis investigations on returned products, complaints, and nonconformances. You will apply structured problem-solving methods and collaborate across functions to identify root causes and drive CAPA implementations.

The role requires a strong background in medical device regulations (FDA 21 CFR Part 820, ISO 13485) and hands-on experience with analytical techniques.