Sr. Quality Engineer, Failure Analysis

Becton Dickinson; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

BD Irvine is seeking a Senior Quality Engineer focused on failure analysis to investigate complaints and nonconformances across medical devices. You will apply 8D, 5-Why, FMEA, and microscopy to identify root causes and drive CAPAs.

You will collaborate with cross-functional teams, document findings for regulatory inspections, and help improve product quality in a fast-paced environment compliant with ISO 13485 and FDA requirements.

Qualifications

• Bachelor's degree in Engineering or related technical field; Master's preferred.
• 5+ years in a quality engineering role with failure analysis in medical devices.
• Expertise in FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, DPA, X-ray.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, MDR is desired.
• Strong communication and data-driven conclusions; problem-solving mindset.

Responsibilities

• Lead and conduct failure analysis investigations on returned products, customer complaints, manufacturing nonconformances, and reliability test failures.
• Perform root cause analysis using structured methodologies including 8D, 5-Why, Fishbone, FMEA.
• Develop and execute investigation plans to identify failure mechanisms and validate root causes.
• Use laboratory equipment, analytical tools, and characterization techniques to evaluate product performance and failure modes.
• Author comprehensive technical reports that clearly communicate methods, evidence, findings, conclusions, and recommendations.
• Support complaint handling investigations and provide technical assessments to identify recurring and emerging failure modes.
• Analyze data to identify opportunities for quality and reliability improvement.
• Partner with cross-functional teams to develop, implement, and verify CAPA.
• Support reliability testing, design verification and validation activities, and product robustness assessments.
• Participate in risk management activities, including design FMEA and reliability assessments.
• Recommend design, process, and quality improvements based on investigations.
• Support regulatory inspections, internal audits, and customer inquiries related to product investigations.
• Contribute to development and continuous improvement of failure analysis methods and lab capabilities.
• Present technical findings at cross-functional and management reviews.

Skills

Failure analysis

Root cause analysis

8D problem solving

5-Why

FMEA

Statistical analysis

Cross-functional collaboration

Technical report writing

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

FTIR

SEM/EDX

Microscopy

X-ray

Statistics software

Job description

We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Job Responsibilities:

• Lead and conduct failure analysis investigations on returned products, customer complaints, manufacturing nonconformances, and reliability test failures.
• Perform root cause analysis using structured problem-solving methodologies, including 8D, 5-Why, Fishbone Analysis, Fault Tree Analysis, and Failure Modes and Effects Analysis (FMEA).
• Develop and execute investigation plans to identify failure mechanisms and validate root causes.
• Use laboratory equipment, analytical tools, and characterization techniques to evaluate product performance and failure modes.
• Author comprehensive technical reports that clearly communicate methods, evidence, findings, conclusions, and recommendations.
• Support complaint handling investigations and provide technical assessments to identify recurring and emerging failure modes.
• Analyze product, manufacturing, reliability, and field-performance data to identify opportunities for quality and reliability improvement.
• Partner with cross-functional teams to develop, implement, and verify corrective and preventive actions (CAPA).
• Support reliability testing, design verification and validation activities, and product robustness assessments.
• Participate in risk management activities, including design FMEA and reliability assessments.
• Recommend design, process, and quality improvements based on investigative findings.
• Support regulatory inspections, internal audits, and customer inquiries related to product investigations.
• Contribute to the development and continuous improvement of failure analysis methods, laboratory capabilities, and best practices.
• Present technical findings at cross-functional and management reviews.
• Perform other incidental duties as assigned.

Job Qualifications:

• Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Materials Science) or a related technical field. Master's degree preferred.
• Minimum of 5 years of experience in a quality engineering role with a strong focus on failure analysis within the medical device industry.
• Proven expertise in various failure analysis methodologies and analytical techniques (e.g., FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, DPA, X-ray).
• Strong knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR).
• Demonstrated ability to lead complex technical investigations and provide clear, concise, and data-driven conclusions.
• Excellent written and verbal communication skills, with the ability to present technical information effectively to diverse audiences.
• Proficiency in statistical analysis software and tools.
• Strong problem-solving skills and a proactive approach to identifying and resolving quality issues.
• Ability to work independently and as part of a cross-functional team in a fast-paced environment.
• ASQ certifications (e.g., CQE, CRE) are a plus.
• Six-Sigma Black Belt Certification is a plus.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers .

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA CA - Irvine Laguna Canyon

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.

Benefits may include:

Health & Well-being: Medical, dental, vision, heal