Medical Device Complaints Investigator - Root-Cause Engineer

Amgen SA; Thousand Oaks (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Flexible work models

Total Rewards Plan

Stock-based long-term incentives

Job summary

Amgen in Thousand Oaks, CA is seeking an Engineer - Complaints Technical Investigator to join the Complaints Trending and Investigation group. You will conduct forensic evaluations of complaint units and support root cause analysis across product design and usability.

You’ll lead cross-functional investigations, apply tools like FMEA and IST, develop methods, and generate final reports following established procedures. A Master’s degree and 5+ years in medical devices preferred.

Qualifications

• Master’s degree in Science or related field required or 5+ years in complaints or failure analysis investigation within a development or manufacturing environment
• Experience with medical devices (Class II/III) and ISO 14971 risk management preferable
• Strong technical writing and cross-functional collaboration abilities

Responsibilities

• Lead evaluation of returned product and batch records
• Provide input to engineering for product improvements
• Partner with device engineering for structured failure analysis processes
• Lead root cause analyses to identify failure modes
• Perform failure analysis using tools like fishbone diagrams and 5 Whys
• Lead cross-functional ideation to reduce complaints and support implementation
• Generate final reports per procedures and requirements
• Train staff on equipment use and validate test methods

Skills

Root cause analysis

Technical writing

Risk analysis

Data analysis

Cross-functional collaboration

Education

Master’s degree in Science or related field

Bachelor’s degree with 2 years of operations experience

Associate’s degree with 6 years of operations experience

High school diploma with 8 years of operations experience

Tools

CT scanners

Instron tensile tester

SEM

FMEA tools

Job description

Amgen in Thousand Oaks, CA is seeking an Engineer - Complaints Technical Investigator to join the Complaints Trending and Investigation group. You will conduct forensic evaluations of complaint units and support root cause analysis across product design and usability.

You’ll lead cross-functional investigations, apply tools like FMEA and IST, develop methods, and generate final reports following established procedures. A Master’s degree and 5+ years in medical devices preferred.