Sr. Quality Engineer, Failure Analysis

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.

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.
  

• 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.