Sr. Quality Engineer, Failure Analysis

Hardware FYI; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Medical insurance

Dental & vision

401(k) with match

Paid time off

Life & disability insurance

Employee assistance program

Job summary

BD is a leading medical technology company seeking a Quality Engineer focused on failure analysis in Irvine, CA. You will lead investigations, apply structured problem-solving methods, and communicate findings to cross-functional teams.

The role emphasizes CAPA, regulatory compliance, and continuous improvement to enhance product reliability. Ideal candidates have 5+ years in quality engineering for medical devices, strong analytical skills, and familiarity with FDA/ISO standards.

Qualifications

• Bachelor's degree in engineering or related technical field; master's preferred.
• Minimum of 5 years in a quality/Failure Analysis role within medical devices.
• Expertise in FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, X-ray.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, MDR.
• Able to lead complex investigations and present data-driven conclusions.
• Excellent written and verbal communication with diverse audiences.
• Proficient in statistical analysis software and tools.
• ASQ CQE/CRE and Six-Sigma Black Belt are pluses.

Responsibilities

• Lead and conduct failure analysis investigations on returned products and complaints.
• Perform root cause analysis using structured methodologies (8D, 5-Why, FMEA).
• Develop and execute investigation plans to identify failure mechanisms.
• Use lab equipment and characterization techniques to evaluate performance.
• Author comprehensive technical reports with methods, findings and recommendations.
• Support complaint handling investigations and identify recurring failure modes.
• Analyze data to identify quality and reliability improvement opportunities.
• Collaborate with cross-functional teams to implement CAPA.
• Support reliability testing, design verification and validation activities.
• Participate in risk management, design FMEA and regulatory inspections.

Skills

Failure analysis

Root cause analysis

8D, 5-Why, Fishbone, FMEA

Statistical analysis

Communication skills

Regulatory knowledge

Independent & cross-functional work

Education

Bachelor's degree in Engineering

Master's degree preferred

ASQ CQE

CRE

Six-Sigma Black Belt

Tools

Microscopy

FTIR

SEM/EDX

X-ray

DPA

Job description

We are the people who give possibilities purpose

BD 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: Responsibilities include but are not limited to:

• 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

Work Shift

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, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.
• Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.
• Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.
• Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.

Additional details regarding benefits and well-being programs can be found in

Our Commitment to You

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00 USD Annual