Principal Engineer - Complaint Technical Investigations

The Principal Engineer will serve as a Subject Matter Expert (SME) in Root Cause Analysis (RCA), providing technical leadership for complex complaint investigations across Amgen's product and device platforms. This role requires exceptional investigative capabilities, critical and analytical thinking, structured problem-solving skills, and technical writing expertise.

Job Responsibilities

• Serve as an RCA Subject Matter Expert, providing technical leadership, guidance, and oversight for complex product and device complaint investigations.
• Independently lead complex technical investigations, applying critical thinking, structured problem-solving methodologies, and scientific and engineering principles to identify root causes and contributing factors.
• Develop and execute robust investigation strategies, including hypothesis development, technical assessments, failure analysis, and evaluation of manufacturing, design, and product performance data.
• Critically evaluate investigation findings, challenge assumptions, identify gaps in technical evidence, and ensure root cause conclusions are scientifically sound, data-driven, and defensible.
• Author and critically review complex technical investigation reports, ensuring clear, concise, and accurate documentation of investigation methodologies, supporting evidence, technical rationale, and conclusions.
• Establish and maintain strong cross-functional partnerships with Device Engineering/Development, Manufacturing, External Supply, Quality, and other stakeholders.
• Lead the integration of digital tools, advanced analytics, automation, and AI-enabled capabilities into RCA workflows.
• Apply advanced RCA methodologies, including 5 Whys, Fishbone Analysis, FMEA, Fault Tree Analysis, tolerance analysis, statistical analysis, and other structured problem-solving techniques.
• Leverage complaint trending, consolidated investigations, and product performance data to identify emerging issues, systemic failure mechanisms, and opportunities for product and process improvements.
• Drive continuous improvement of RCA methodologies, investigation procedures, technical standards, and knowledge-sharing practices.
• Provide technical coaching and mentorship to investigators, promoting critical thinking, scientific rigor, effective problem-solving, and technical writing excellence.
• Communicate complex technical findings, investigation outcomes, and recommendations to cross-functional stakeholders and management.
• Support functional objectives, quality system improvements, and initiatives focused on enhancing product reliability, patient experience, and operational excellence.

Basic Qualifications

• Doctorate degree and 2 years of operations experience OR
• Master's degree and 4 years of operations experience OR
• Bachelor's degree and 6 years of operations experience OR
• Associate's degree and 10 years of operations experience OR
• High school diploma / GED and 12 years of operations experience

Preferred Qualifications

• Advanced degree in Science.
• Extensive experience conducting and leading complex technical investigations, failure analysis, and root cause investigations within pharmaceutical, biotechnology, medical device, or combination-product environments.
• Demonstrated subject matter expertise in RCA methodologies, including structured problem-solving, hypothesis development, failure mechanism identification, and scientifically defensible root cause determinations.
• Exceptional critical thinking, analytical reasoning, and problem-solving capabilities.
• Excellent technical writing skills, with proven experience independently authoring and critically reviewing complex investigation reports, technical assessments, scientific justifications, and regulatory-quality documentation.
• Strong technical knowledge of medical devices, combination products, manufacturing processes, product design, and associated failure mechanisms.
• Demonstrated ability to establish strong technical networks and influence cross-functional stakeholders across Engineering, Manufacturing, External Supply, Quality, and related organizations.
• Experience integrating digital tools, automation, advanced analytics, or AI-enabled solutions into technical investigation processes or quality workflows.
• Strong knowledge of statistical analysis, Six Sigma methodologies, risk management principles, ISO 14971, and relevant quality system requirements.
• Experience leading continuous improvement initiatives to enhance investigation effectiveness, standardization, technical quality, and operational efficiency.
• Demonstrated ability to mentor technical professionals, share best practices, and influence technical decisions without direct reporting authority.
• Strong interpersonal, communication, and presentation skills, with the ability to translate complex technical findings into clear recommendations for technical and management audiences.