HOW MIGHT YOU DEFY IMAGINATION?

　　You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

　　Engineer - Complaints Technical Investigator

　　Live

　　What you will do

　　Let’s do this. Let’s change the world.

　　Amgen is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation 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 Engineer - Complaints Technical Investigator conducts technical investigations of Level 2 and 3 complaints associated with product design and/ or usability issues and conducts trend and consolidated investigations using data analytics. This role understands customer/ patient use of Amgen’s packaged and/or distributed products, as well as manufacturing processes for these products. The Complaints Technical Investigator owns CAPA’s to support identifying design solutions 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 helping with investigation lab infrastructure, equipment setup, personnel training and method development and validation.

　　Job responsibilities:

　　Lead root cause analysis to identify the failure mode for Amgen’s products and associated components due to product complaint

　　Perform 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. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.

　　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 implementation

　　Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends

　　Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends

　　Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data

　　Develop and perform relational data analytics in support of investigations

　　Advise management for trend and failure investigation process improvement

　　Provide recommendations to engineering for product improvements

　　Manage, coach and mentor staff

　　Support functional management initiatives and objectives

　　Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

　　Requires a combination of working remote and going onsite 2 to 3 times per week (average) for complaint returns assessment and/or laboratory equipment setup, development and validation of test methods.

　　Win

　　What we expect of you

　　We 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:

　　Master’s degree OR

　　Bachelor’s degree and 2 years of Operations experience OR

　　Associate’s degree and 6 years of Operations experience OR

　　High school diploma/GED and 8 years of Operations experience

　　Preferred Qualifications:

　　Master’s Degree in Science

　　10+ years of progressive and relevant experience

　　5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III

　　Proven experience with medical devices

　　Demonstrated Six Sigma proficiency specifically for root cause analysis methodology

　　Experience 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 experiments

　　Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives

　　Strong technical writing and interpersonal skills

　　Thrive

　　What you can expect of us

　　As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

　　Amgen offers a Total Rewards Plan comprising 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 including:

　　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 and bi-annual company-wide shutdowns

　　Flexible work models, including remote work arrangements, where possible

　　Apply now

　　for a career that defies imagination

　　Objects in your future are closer than they appear. Join us.

　　careers.amgen.com

　　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.

　　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.