Senior Engineer - Complaints Technical Investigations

This senior engineering role investigates complex product complaints related to drug delivery device design and usability at Amgen's Thousand Oaks facility. The position conducts root cause analyses, leads cross-functional design solutions, and performs trend investigations using data analytics and established methodologies. The engineer coordinates corrective actions and collaborates with quality and engineering teams to drive product improvements.

Responsibilities

• Lead root cause analysis and failure mode identification for product complaints using fishbone diagrams, 5 Whys, FMEA, and Fault Tree Analysis
• Conduct trend and consolidated investigations with statistical data assessment to identify patterns
• Lead cross-functional ideation of design solutions and determine feasibility through testing and analysis
• Generate investigation reports with data collection and statistical analysis per established procedures
• Manage, coach, and mentor engineering staff on complaint and failure investigation processes

Requirements

• Bachelor's degree and 4 years of operations experience minimum
• 5+ years complaints or failure analysis in medical device development or manufacturing
• Six Sigma proficiency for root cause analysis methodology
• Experience with ISO 14971 risk management and FMEA tools
• Strong technical writing and interpersonal communication skills
• Advanced degree in science preferred