Sr. Quality Engineer, Failure Analysis

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

Pay and benefits

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. Required Skills Optional Skills.

Primary Work Location USA CA - Irvine Laguna Canyon Additional Locations 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