Sr. Quality Engineer, Failure Analysis

Becton Dickinson NA; Irvine (CA); Presencial; USD 106.000 - 169.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Retirement plan

Paid time off

Descripción de la vacante

Becton, Dickinson, and Company is a global medical technology leader seeking an experienced Quality Engineer focused on failure analysis to lead investigations and drive CAPA across products and processes in Irvine, CA. Strong analytical and communication skills are essential.

Responsibilities include root cause analysis, testing, and reporting, with exposure to FDA/regulatory requirements and ISO 13485. A 5+ year background in medical device QA is required.

Formación

• Bachelor's degree in Engineering or related technical field (Biomedical/Mechanical/Electrical/Materials).
• Master's degree preferred.
• Minimum of 5 years in a quality engineering role focused on failure analysis in medical devices.
• Expertise in failure analysis methodologies and analytical techniques (FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, DPA, X-ray).
• Strong knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, MDR).
• ASQ CQE/CRE and Six-Sigma Black Belt are a plus.
• Excellent written and verbal communication and data-driven conclusions are required.

Responsabilidades

• 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, and 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 communicating 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 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 and best practices.
• Present technical findings at cross-functional and management reviews.
• Perform other incidental duties as assigned.

Conocimientos

FMEA

8D

Ishikawa

SEM/EDX

X-ray

Root cause analysis

Statistical analysis

Educación

Bachelor's in Engineering

Master's degree preferred

Six-Sigma Black Belt

ASQ CQE/CRE

Herramientas

FTIR

SEM/EDX

X-ray

Descripción del empleo

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 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.

Required SkillsOptional Skills

Primary Work Location USA CA - Irvine Laguna Canyon

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 .

Salary Range Information

$105,500.00 - $168,800.00 USD Annual

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 displayedOur 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 rate 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.