{"id":3238300,"url":"https://alion.io/job/bd-sr-quality-engineer-failure-analysis","title":"Sr. Quality Engineer, Failure Analysis","company":{"id":1821,"name":"BD","domain":"bd.com","url":"https://alion.io/company/bd","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":45,"ghost_share":0,"stale_share":0.511,"repost_share":0.044,"time_to_fill_p50_days":32,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":105500,"max":168800,"currency":"USD","period":"year","gross":null,"usd_annual":168800},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-27T18:23:29Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"We are the people who give possibilities purpose\nBD 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.\n\nJob Description\nJob Responsibilities:\nResponsibilities include but are not limited to:\nLead and conduct failure analysis investigations on returned products, customer complaints, manufacturing nonconformances, and reliability test failures.\nPerform root cause analysis using structured problem-solving methodologies, including 8D, 5-Why, Fishbone Analysis, Fault Tree Analysis, and Failure Modes and Effects Analysis (FMEA).\nDevelop and execute investigation plans to identify failure mechanisms and validate root causes.\nUse laboratory equipment, analytical tools, and characterization techniques to evaluate product performance and failure modes.\nAuthor comprehensive technical reports that clearly communicate methods, evidence, findings, conclusions, and recommendations.\nSupport complaint handling investigations and provide technical assessments to identify recurring and emerging failure modes.\nAnalyze product, manufacturing, reliability, and field-performance data to identify opportunities for quality and reliability improvement.\nPartner with cross-functional teams to develop, implement, and verify corrective and preventive actions (CAPA).\nSupport reliability testing, design verification and validation activities, and product robustness assessments.\nParticipate in risk management activities, including design FMEA and reliability assessments.\nRecommend design, process, and quality improvements based on investigative findings.\nSupport regulatory inspections, internal audits, and customer inquiries related to product investigations.\nContribute to the development and continuous improvement of failure analysis methods, laboratory capabilities, and best practices.\nPresent technical findings at cross-functional and management reviews.\nPerform other incidental duties as assigned.\nJob Qualifications:\nBachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Materials Science) or a related technical field. Master's degree preferred.\nMinimum of 5 years of experience in a quality engineering role with a strong focus on failure analysis within the medical device industry.\nProven expertise in various failure analysis methodologies and analytical techniques (e.g., FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, DPA, X-ray).\nStrong knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR).\nDemonstrated ability to lead complex technical investigations and provide clear, concise, and data-driven conclusions.\nExcellent written and verbal communication skills, with the ability to present technical information effectively to diverse audiences.\nProficiency in statistical analysis software and tools.\nStrong problem-solving skills and a proactive approach to identifying and resolving quality issues.\nAbility to work independently and as part of a cross-functional team in a fast-paced environment.\nASQ certifications (e.g., CQE, CRE) are a plus.\nSix-Sigma Black Belt Certification is a plus.\nWhy Join Us?\nTo 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.\nWe 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.\nTo learn more about BD visithttps://bd.com/careers.\nBecton, 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.\nRequired Skills\nOptional Skills\n.\nPrimary Work Location\nUSA CA - Irvine Laguna CanyonAdditional Locations\nWork Shift\n\nAt 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.\nBenefits may include:\nHealth & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.\nRetirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.\nWork-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.\nLeave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.\nAdditional details regarding benefits and well-being programs can be found in Our Commitment to You.\nOur 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\nOur 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.\nSalary Range Information\n$105,500.00 - $168,800.00 USD Annual","description_format":"text","description_chars":6442,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-10-25T13:53:49Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":5,"expected_fill_days":32,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":168800,"is_top_pay":true},"html_url":"https://alion.io/job/bd-sr-quality-engineer-failure-analysis","json_url":"https://alion.io/job/bd-sr-quality-engineer-failure-analysis.json","meta":{"generated_at":"2026-10-27T23:19:10Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":15261,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1821},"rest":"https://alion.io/mcp/rest/get_company?id=1821"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbd-sr-quality-engineer-failure-analysis"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbd-sr-quality-engineer-failure-analysis"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbd-sr-quality-engineer-failure-analysis"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/bd-sr-quality-engineer-failure-analysis\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbd-sr-quality-engineer-failure-analysis"}]}