Sr. Quality Engineer, Failure Analysis
Onsite, Irvine, CA
- Job ID
- R-557988
- Category
- Engineering
- Location
- Irvine, California
Build an engineering career where innovation, ownership and impact move healthcare forward
At BD, Engineering and R&D professionals design, develop and improve the technologies that shape how healthcare is delivered worldwide. You'll apply scientific thinking, technical expertise and creative problem-solving to turn complex challenges into solutions that matter.
Whether you specialize in mechanical, electrical, process, systems, software or research engineering, BD offers the scale, resources and freedom to innovate – with clear expectations, accountability for outcomes and opportunities to grow your career alongside industry-leading technology.
And as one of the world's largest medical technology companies, you'll shape solutions that reach across global healthcare systems and improve lives at scale.
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.
Required Skills
Optional Skills
.
Primary Work Location
USA CA - Irvine Laguna CanyonAdditional 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 AnnualSuccess Profile
What sets successful Engineering and R&D professionals apart? You're likely to thrive if you are:
- Analytical
- Collaborative
- Curious
- Detail-oriented
- Inventive
- Problem-solver
Ready for your next challenge?
This is an environment for engineers who want to think boldly and execute with precision. You'll have the opportunity to influence design decisions, contribute across the full product lifecycle and see how your work moves from concept to real-world impact – backed by the scale of a global MedTech leader.
Hear from one of our BD Innovators about how BD uses cutting-edge AI and machine learning to power decisions that improve patient outcomes and expand access to care. This is where your work drives real-time impact across the globe.
Hear from Our Associates
-

"BD is a big, global company so don't be afraid to connect with and reach out to others. There is so much to learn here, and the company does an amazing job of helping people develop and grow. I'd also offer to become like a sponge and soak up as much knowledge as you can and put your Career Blueprint to work for you. I really love my job and am so grateful to work at BD."
-

"I think we have something like more than 30 different countries represented by those working within the Research Centre Ireland, which is impressive and one of my favourite things about BD. I work with electrical, mechanical engineers, scientists and so many others – it's wonderful to see and hear so many different perspectives during the day."
-

"I continue to be amazed at how we keep innovating in the Med Tech space. We constantly evaluate how to bring even more solutions to healthcare professionals, how to increase the efficiency of our technologies, all while keeping the patient impact in mind. Not only have I found meaningful work at BD, but a place where I feel I can thrive."
-

"During my interview, I learned how much of an impact our infusion solutions have across the world and I was impressed because whether it's analgesics, cancer treatments, anesthesia or other treatments, the likelihood of someone within your own family using our product is high. Contributing to the creation of products that have the ability to make such a big impact in healthcare is a great feeling. I love my role at BD."
Looks like you haven't viewed any jobs yet, search open opportunities now.
Looks like you haven't saved any jobs yet, search open opportunities now.
Join our Talent PoolSign up to get the latest company news, events, and future opportunities straight to your inbox. |
Sign up for Job AlertsCreate a job alert and be notified when opportunities matching your skills and location become available. |