Senior Engineer - Complaints & Root Cause Investigations

Biopharma Careers; Thousand Oaks (CA); On-site; USD 115,000 - 156,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Performance bonus

Flexible work arrangements

Job summary

Amgen in Thousand Oaks, CA is seeking a Senior Engineer for Complaints Technical Investigations to lead root cause analysis and coordinate failure investigations for medical devices associated with product complaints.

The role requires strong experience in statistical methods, risk assessment (ISO 14971), and cross-functional collaboration to develop design improvements and prevent recurrence across programs.

Qualifications

• PhD or Master’s with related experience in operations or equivalent
• Bachelor’s with 4 years of operations experience or higher and related fields
• Associate’s with 8 years of operations experience or higher
• High school diploma with 10 years of operations experience

Responsibilities

• Lead root cause analysis to identify the failure mode for Amgen’s products and associated components due to product complaint
• Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, “5 Whys”, risk assessments such as FMEA’s, Fault Tree Analysis, or tolerance analysis
• Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
• Perform technical trends and consolidated investigations, including statistical assessment of data to identify trends
• Support the evaluation of returned products, product reserve sample inspections, batch records and review of complaint history and trends
• Generate final investigation reports in accordance with established procedures, which may include data collection and statistical analysis of the data
• Develop and perform relational data analytics in support of investigations
• Advise management for trend and failure investigation process improvement
• Provide input to engineering for product improvements
• Manage, coach and mentor staff
• Support functional management initiatives and objectives

Skills

Root cause analysis

Failure analysis

Statistical analysis

Six Sigma

Risk management

Education

Doctorate degree

Master’s degree (2 years exp)

Bachelor’s degree (4 years exp)

Associate’s degree (8 years exp)

Job description

Amgen in Thousand Oaks, CA is seeking a Senior Engineer for Complaints Technical Investigations to lead root cause analysis and coordinate failure investigations for medical devices associated with product complaints.

The role requires strong experience in statistical methods, risk assessment (ISO 14971), and cross-functional collaboration to develop design improvements and prevent recurrence across programs.