Senior Engineer, Medical Device Complaints & Investigations

Amgen; Thousand Oaks (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Sr. Engineer - Complaints Technical Investigator in Thousand Oaks, CA. This role leads technical investigations of advanced complaints, owns CAPAs based on root cause, and collaborates with engineering and quality to drive product improvements.

You will mentor staff and participate in multi-functional design initiatives to optimize patient experiences. The position emphasizes root cause analysis, data analytics, and cross-functional collaboration, with opportunities to

Qualifications

• Doctorate or Master’s with operations experience in a relevant field.
• Experience in medical devices or development/manufacturing environments.
• Strong root cause analysis and data analysis capabilities.
• Familiarity with ISO 14971 risk management and quality processes.

Responsibilities

• Lead root cause analysis to identify failure modes of Amgen products and components.
• Perform failure analysis using RCA tools and risk assessments (FMEA, FTA, tolerance analysis).
• Lead cross-functional ideation of design solutions to reduce complaints.
• Conduct trend and consolidated investigations with statistical assessments.
• Support evaluation of returned products and batch records for trends.
• Generate final investigation reports per established procedures.

Skills

Six Sigma proficiency

Technical writing

Interpersonal skills

Root cause analysis

Data analytics

Leadership/mentoring

Education

Doctorate degree

Master’s degree in operations or related field

Bachelor’s degree in operations

Associate’s degree in operations

High school diploma / GED with experience

Job description

Amgen is seeking a Sr. Engineer - Complaints Technical Investigator in Thousand Oaks, CA. This role leads technical investigations of advanced complaints, owns CAPAs based on root cause, and collaborates with engineering and quality to drive product improvements.

You will mentor staff and participate in multi-functional design initiatives to optimize patient experiences. The position emphasizes root cause analysis, data analytics, and cross-functional collaboration, with opportunities to