Principal Engineer - Complaint Technical Investigations

1001 Amgen Inc.; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Stock-based incentives

Job summary

Amgen Inc. is seeking a Principal Engineer for Complaints Technical Investigations to lead complex product and device RCA efforts.

You will guide investigations with rigorous scientific reasoning, develop robust assessment strategies, and champion data analytics and AI-enabled enhancements across RCA workflows. Collaboration across Manufacturing, Quality, Device Engineering, External Supply, and IT will be essential.

Qualifications

• Advanced degree and extensive experience leading complex investigations within pharmaceutical/biotech/medical device environments.
• Proven expertise in RCA methodologies and structured problem-solving with defensible conclusions.
• Excellent technical writing and ability to translate complex findings for diverse audiences.
• Strong interpersonal skills to influence cross-functional stakeholders without direct authority.
• Experience integrating data analytics, automation, and AI-enabled tools into QA/RCAs.

Responsibilities

• Serve as RCA SME, providing technical leadership for complex investigations.
• Lead investigations with hypothesis development, failure analysis, and data review.
• Develop robust investigation strategies and evaluate evidence for root causes.
• Author and review complex technical investigation reports with clear justification.
• Cultivate cross-functional partnerships to drive corrective actions and knowledge sharing.
• Lead adoption of digital tools and analytics in RCA workflows.

Skills

RCA methodologies

Critical thinking

Technical writing

Cross-functional collaboration

Data analytics

Education

Doctorate degree

Master's degree

Bachelor's degree

Tools

Six Sigma

FMEA

ISO 14971

Job description

Principal Engineer - Complaint Technical Investigations

Career Category Engineering Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let’s do this. Let’s change the world. Amgen is currently seeking a Principal Engineer – Complaints Technical Investigations within our Complaints Technical Investigation (CTI) organization. In support of Amgen's mission to serve patients, our team is dedicated to continuously improving clinical and commercial products and drug delivery devices to enhance product quality, ensure supply continuity, and optimize the patient experience. The Principal Engineer – Complaints Technical Investigations 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. The successful candidate will independently lead complex investigations, critically evaluate technical evidence, challenge assumptions, and ensure scientifically sound and defensible root cause conclusions. The individual will establish strong cross‑functional partnerships with Device Engineering/Development, Manufacturing, External Supply, Quality, and other technical organizations to drive investigation outcomes and identify opportunities for product and process improvements. Additionally, the Principal Engineer will champion the integration of digital tools, advanced data analytics, automation, and AI‑enabled technologies into RCA processes, improving investigation efficiency, consistency, and technical rigor.

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 to facilitate comprehensive investigations and drive alignment on root cause determinations and corrective actions.
• Lead the integration of digital tools, advanced analytics, automation, and AI‑enabled capabilities into RCA workflows, identifying opportunities to improve investigation quality, efficiency, data interpretation, and technical documentation.
• 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 to strengthen organizational investigation capabilities.
• 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 to support risk‑based decisions and timely resolution of product quality issues.
• Support functional objectives, quality system improvements, and initiatives focused on enhancing product reliability, patient experience, and operational excellence.

What we expect of you

• Doctorate degree and 2 years of operations experience
• Master’s degree and 4 years of operations experience
• Bachelor’s degree and 6 years of operations experience
• Associate’s degree and 10 years of operations experience
• 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, with demonstrated ability to evaluate complex technical information, challenge assumptions, and develop evidence‑based conclusions.
• 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.

What you can expect of us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible.

Salary Range 140,334.15USD -189,863.85 USD

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen