Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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.Senior Engineer - Complaints Technical InvestigationsWhat you will doLet’s do this! Let’s change the world! Amgen is currently seeking a Sr. Engineer - Complaints Technical Investigator in our Complaints Technical Investigations group. In support of Amgen’s mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.The Sr. Engineer - Complaints Technical Investigator conducts technical investigations of Advanced complaints associated with product design and/or usability issues and conducts trend and consolidated investigations using data analytics and root cause investigation methodologies. This role understands customer/ patient use of Amgen’s packaged and/or distributed products, as well as manufacturing processes for these products. The Sr. Engineer - Complaints Technical Investigator owns CAPA’s based on root cause and will also participate in multi-functional ideation of design solutions. Also maintains close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities also include complaint sample evaluations, investigation plans, and personnel training.JOB RESPONSIBILITIES:Lead root cause analysis to identify the failure mode for Amgen’s products and associated components due to product complaintPerform 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 implementationPerform technical trends and consolidated investigations, including statistical assessment of data to identify trendsSupport the evaluation of returned products, product reserve sample inspections, batch records and review of complaint history and trendsGenerate final investigation reports in accordance with established procedures, which may include data collection and statistical analysis of the dataDevelop and perform relational data analytics in support of investigationsAdvise management for trend and failure investigation process improvementProvide input to engineering for product improvementsManage, coach and mentor staffSupport functional management initiatives and objectivesWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:Doctorate degree ORMaster’s degree and 2 years of operations experience ORBachelor’s degree and 4 years of operations experience ORAssociate’s degree and 8 years of operations experience ORHigh school diploma / GED and 10 years of operations experiencePreferred Qualifications:Advanced Degree in Science10+ years of progressive and relevant experience5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class IIIProven experience with medical devicesDemonstrated Six Sigma proficiency specifically for root cause analysis methodologyExperience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)Experience with protocol and report writing, process and test development and execution, and design of experimentsExperience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiativesStrong technical writing and interpersonal skillsWhat you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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.Application deadlineAmgen anticipates accepting applications until August 19, 2026; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.SponsorshipSponsorship for this role is not guaranteed.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status..Salary Range115,494.60USD -156,257.40 USD