Senior Engineer, Complaints & Investigations Leader

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Bonuses

Flexible work model

Job summary

Amgen is seeking a Senior Engineer - Complaints Technical Investigator in Thousand Oaks, CA, to lead technical investigations of advanced product complaints and CAPA ownership. The role requires deep root-cause analysis, data analytics, and cross-functional collaboration with engineering and quality teams.

The position offers a total rewards package including bonuses and flexible work models. You will mentor staff while driving product improvements and ensuring patient safety and quality

Qualifications

• Advanced degree in Science (Preferred)
• 10+ years of progressive and relevant experience
• 5+ years of experience in complaints or failure analysis investigations in medical devices
• Proven experience with medical devices and ISO 14971 risk management
• Six Sigma proficiency for root cause analysis
• Experience with protocol and report writing, process and test development and DOE
• Leadership of continuous improvement initiatives with quality focus
• Strong technical writing and interpersonal skills

Responsibilities

• Lead root cause analysis to identify failure modes for products and components
• Perform failure analyses using fishbone diagrams, 5 Whys, FMEA, Fault Tree Analysis
• Lead cross-functional ideation to design solutions and feasibility testing
• Perform technical trend and consolidated investigations with statistical analysis
• Evaluate returned products, inspect batch records, review history and trends
• Generate final investigation reports per established procedures with data analysis
• Develop relational data analytics in support of investigations
• Advise management on trend and process improvements
• Provide input to engineering for product improvements
• Manage, coach and mentor staff
• Support functional management initiatives and objectives

Skills

Six Sigma proficiency

Technical writing

Interpersonal skills

Root cause analysis

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma / GED

Job description

Amgen is seeking a Senior Engineer - Complaints Technical Investigator in Thousand Oaks, CA, to lead technical investigations of advanced product complaints and CAPA ownership. The role requires deep root-cause analysis, data analytics, and cross-functional collaboration with engineering and quality teams.

The position offers a total rewards package including bonuses and flexible work models. You will mentor staff while driving product improvements and ensuring patient safety and quality