Senior Engineer - Complaints Technical Investigations

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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 Investigations

What you will do

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

Amgen is currently seeking a Sr. 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 Sr. Complaints Technical Investigator conducts technical investigations, including root cause analysis, for 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 Sr. 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. They also maintain close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities also include evaluation of returned product using equipment such as CT scanners, support 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 multi-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

• Lead technical trend and consolidated investigations, including statistical assessment of data to identify cause of 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.

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:

• Doctorate degree OR

• Master’s degree and 2 years of medical/biopharma development, engineering or post-market experience OR

• Bachelor’s degree and 4 years of medical/biopharma development, engineering or post-market experience OR

• Associate’s degree and 8 years of medical/biopharma development, engineering or post-market experience OR

• High school diploma / GED and 10 years of medical/biopharma development, engineering or post-market 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

What you can expect from us

As 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 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.