Senior Engineer: Complaints & Root-Cause Investigator

Amgen SA; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement benefits

Flexible work models

Generous time-off plans

Job summary

Amgen is seeking a Senior Engineer - Complaints Technical Investigator to lead advanced investigations of product complaints and to improve patient experience. You will own CAPAs based on root cause analyses and collaborate with engineering and quality functions to drive product improvements.

Expect to mentor staff and develop data-driven investigation plans. The role emphasizes scientific rigor, risk analysis (ISO 14971), and cross-functional teamwork within a dynamic biopharma environment in

Qualifications

• Doctorate or Master’s degree with operations experience preferred.
• Bachelor’s degree with 4 years operations experience or higher is acceptable.
• Associate’s degree with 8 years operations experience acceptable.
• High school diploma or GED with 10 years operations experience acceptable.
• Experience with medical devices and regulatory frameworks is a plus.

Responsibilities

• Lead root cause analysis to identify failure modes in Amgen products.
• Perform failure analysis using FMEA, FTA, and other tools.
• Drive cross-functional ideation and design solution feasibility testing.
• Conduct trend analysis and consolidate investigation data.
• Prepare final investigation reports per established procedures.
• Develop relational data analytics to support investigations.
• Advise on process improvements and product enhancements.
• Mentor and coach staff within the investigations group.
• Support management initiatives and objectives.

Skills

Root cause analysis

Data analytics

Six Sigma

Technical writing

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

FMEA

Fault Tree Analysis

5 Whys

Fishbone diagrams

Job description

Amgen is seeking a Senior Engineer - Complaints Technical Investigator to lead advanced investigations of product complaints and to improve patient experience. You will own CAPAs based on root cause analyses and collaborate with engineering and quality functions to drive product improvements.

Expect to mentor staff and develop data-driven investigation plans. The role emphasizes scientific rigor, risk analysis (ISO 14971), and cross-functional teamwork within a dynamic biopharma environment in