Senior Engineer - Complaints Technical Investigations
Amgen
August 20, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Senior Engineer - Complaints Technical Investigations
What You Will Do
- Conduct technical investigations of product complaints related to design and/or usability issues.
- Perform technical trend and consolidated investigations using data analytics and root-cause methodologies.
- Own CAPAs based on root cause; collaborate cross-functionally on design solutions.
- Maintain interaction with engineering/quality to drive product improvement; evaluate complaint samples, develop investigation plans, and train personnel.
Job Responsibilities
- Lead root cause analysis to identify failure modes.
- Perform failure analysis using tools such as fishbone diagrams, “5 Whys,” FMEA/Fault Tree/tolerance analysis, and risk assessments.
- Lead cross-functional ideation; assess feasibility via testing/analysis; develop implementation business plans.
- Support evaluation of returned products/reserve samples, batch record review, and complaint history/trends.
- Generate investigation reports (including data/statistical analysis) and develop relational data analytics.
- Advise management on process improvements; provide input to engineering; manage/coach/mentor staff.
Basic Qualifications
- Doctorate OR Master’s + 2 years operations OR Bachelor’s + 4 years operations OR Associate’s + 8 years operations OR HS/GED + 10 years operations.
Preferred Qualifications
- Advanced science degree; 10+ years relevant experience.
- 5+ years in complaints or failure analysis in development/manufacturing for Medical Devices (ideally Class II/III).
- Six Sigma root cause methods; ISO 14971 risk management; protocol/report writing; DoE/process/test execution; continuous improvement leadership; strong technical writing/interpersonal skills.
Benefits (if eligible)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending; annual bonus/incentives; stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. Anticipated application acceptance until August 19, 2026.
What You Will Do
- Conduct technical investigations of product complaints related to design and/or usability issues.
- Perform technical trend and consolidated investigations using data analytics and root-cause methodologies.
- Own CAPAs based on root cause; collaborate cross-functionally on design solutions.
- Maintain interaction with engineering/quality to drive product improvement; evaluate complaint samples, develop investigation plans, and train personnel.
Job Responsibilities
- Lead root cause analysis to identify failure modes.
- Perform failure analysis using tools such as fishbone diagrams, “5 Whys,” FMEA/Fault Tree/tolerance analysis, and risk assessments.
- Lead cross-functional ideation; assess feasibility via testing/analysis; develop implementation business plans.
- Support evaluation of returned products/reserve samples, batch record review, and complaint history/trends.
- Generate investigation reports (including data/statistical analysis) and develop relational data analytics.
- Advise management on process improvements; provide input to engineering; manage/coach/mentor staff.
Basic Qualifications
- Doctorate OR Master’s + 2 years operations OR Bachelor’s + 4 years operations OR Associate’s + 8 years operations OR HS/GED + 10 years operations.
Preferred Qualifications
- Advanced science degree; 10+ years relevant experience.
- 5+ years in complaints or failure analysis in development/manufacturing for Medical Devices (ideally Class II/III).
- Six Sigma root cause methods; ISO 14971 risk management; protocol/report writing; DoE/process/test execution; continuous improvement leadership; strong technical writing/interpersonal skills.
Benefits (if eligible)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending; annual bonus/incentives; stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. Anticipated application acceptance until August 19, 2026.