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.
Principal Engineer - Complaint Technical Investigations
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,…