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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Live

What you will do

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

Amgen is currently seeking a Sr. Engineer in our Complaints Trending and Investigation (CT&I) group. This position will report to our Sr Manager. 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 will manage the CT&I lab, leading the implementation, qualification, and operation of the various equipment. S/He will develop the training and training qualification (TRNQ), as applicable, for each equipment, develop and update equipment procedures, oversee the monthly safety inspection, lead discussions with vendors for equipment optimization, and identify appropriate methods and data acquisition activities.

S/He will conduct 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 mechanical and/or electromechanical product as well as manufacturing processes for these products. The Sr. Engineer will own CAPA’s to support identifying design solutions based on root cause and will also participate in multi-functional ideation of design solutions. S/He also maintains close interaction with the engineering and quality functions to contribute to product improvement. Responsibilities may also include evaluation of returned product using equipment such as CT scanners.

Requires a combination of working remote and going onsite for complaint returns assessment and/or laboratory equipment setup, implementation, and qualification.

Job responsibilities:

• Manage the CT&I lab infrastructure, including equipment qualification, personnel training, and operating procedures and collaborate with CPO’s lab manager for the monthly lab safety inspections

• Lead root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices and associated product components such as packaging returned due to product complaint using root cause analysis

• Perform failure analysis using tools and processes to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or Fault Tree 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

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 employee with these qualifications.

Basic qualifications

Doctorate degree

Or

Master’s degree and 3 years of Engineering, Science or Operations experience

Or

Bachelor’s degree and 5 years of Engineering, Science or Operations experience

Or

Associate’s degree and 10 years of Engineering, Science or Operations experience

Or

High school diploma / GED and 12 years of Engineering, Science or Operations experience

Preferred qualifications

• Master’s Degree in Science or Engineering preferably Mechanical, Electrical, or BioMed

• 10+ years of progressive and relevant experience as an Engineer

• 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 mechanical and/or electromechanical 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

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Apply now

for a career that defies imagination

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

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