Senior Engineer, Complaints & Technical Investigations

Amgen; Thousand Oaks (CA); Hybrid; USD 115.000 - 156.000; Vollzeit

Zusammenfassung

Amgen Inc. in Thousand Oaks, CA, is seeking a Senior Engineer - Complaints Technical Investigations to lead technical investigations of advanced complaints related to product design and usability.

You will own CAPAs based on root cause and collaborate with engineering and quality to drive product improvement. The role requires extensive experience in complaints or failure analyses, proficiency with risk analysis per ISO 14971, and strong technical writing.

Qualifikationen

• Advanced degree in science or engineering as required for senior role.
• Experience with medical devices and Class II/III.
• Strong experience in complaints or failure analysis investigations.

Aufgaben

• Lead root cause analysis to identify failure modes for Amgen's products and components.
• Perform failure analysis using methods like fishbone, 5 Whys, FMEA, Fault Tree, tolerance analysis.
• Lead cross-functional ideation of design solutions to reduce complaints and assess feasibility via testing.
• Conduct technical trends and consolidated investigations with statistical assessment.
• Support evaluation of returned products, sample inspections, batch records, and history trends.
• Generate final investigation reports following established procedures with data analysis.
• Develop relational data analytics to support investigations.
• Advise management on trend and process-improvement opportunities.
• Provide input to engineering for product improvements.
• Mentor staff and support functional initiatives.

Kenntnisse

Root cause analysis

Data analytics

Six Sigma

Documentation

Medical devices familiarity

Ausbildung

Doctorate degree

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

FMEA

Statistical software

CAPA processes

Jobbeschreibung

Amgen Inc. in Thousand Oaks, CA, is seeking a Senior Engineer - Complaints Technical Investigations to lead technical investigations of advanced complaints related to product design and usability.

You will own CAPAs based on root cause and collaborate with engineering and quality to drive product improvement. The role requires extensive experience in complaints or failure analyses, proficiency with risk analysis per ISO 14971, and strong technical writing.