New · posted Oct 23
Becton Dickinson · Medical Devices
Sr. Quality Engineer, Failure Analysis
- Irvine, CA
- On-site
- Full-time
- Senior & Principal
Open until filled
What you need
Required Skills
Optional Skills
- 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.
What you'll do
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.
Pay
$105,500 – $168,800 a year
Employer providedSalary Range Information
$105,500.00 - $168,800.00 USD Annual
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.
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.
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAWorking conditions
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.
Primary Work Location
USA CA - Irvine Laguna Canyon
From the posting
About BD
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.
Equal opportunity, accessibility and legal noticesBecton Dickinson's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California91 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,500 | — | $168,800 |
| California (middle half) | $115,750 | $135,500 | $157,250 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
This role: Becton Dickinson's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not BD's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA8
- Lab testing and methods7
- Collaboration and leadership7
- Quality systems and risk4
- GMP and compliance2
- Validation and qualification2
- Documentation and SOPs1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
BD on Regulatory Jobs
- 89
- Open roles
- 78
- Distinct roles
- 20
- Locations
By discipline
- Quality70 79%
- Regulatory17 19%
- Compliance & Safety2 2%
By level
- Senior & Principal44 49%
- Associate & Specialist27 30%
- Manager15 17%
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Sr. Quality Engineer, Failure Analysis at BD
Open until filled. $106K–$169K a year, employer provided.