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Engineer - Technical Investigator

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Sep 13, 2022
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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

The Engineer - 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 identifies 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 tools and processes. Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines may be used. This engineer supports trend investigations through the review of manufacturing batch records, evaluation of returned product, product reserve sample inspections, and review of complaint histories and trends. Upon completion of these activities, this role will support authoring final reports in accordance with established procedures, which may include data collection and statistical analysis of the data. S/he will own CAPAs in support of identifying design solutions based on root cause and will also support cross functional ideation of design solutions.

Live

What you will do

Lets do this. Lets change the world. In this vital role you will maintain close interaction with the engineering and quality functions to contribute to product improvement.

  • Understand customer / patient use of/ manufacturing processes for Amgens packaged and/or distributed mechanical and/or electromechanical products

  • Support technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports

  • Support cross functional ideation of design solutions based on output of root cause analysis

  • Support the development and performance relational data analytics in support of investigations

  • Support failure analysis of mechanical and/or electromechanical product to identify root cause using tools such as tolerance analysis, fishbone diagrams, 5 Whys, and risk assessments such as FMEAs or Fault Tree Analysis

  • CAPA ownership in support of ideation phase

  • Provide input to management for trend and failure investigation process improvement

  • 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 process engineering professional we seek is a collaborative leader with these qualifications.

Basic Qualifications
  • Masters degree OR

  • Bachelors degree and 2 years of engineering or life science experience OR

  • Associates degree and 6 years of engineering or life science experience OR

  • High School diploma/GED and 8 years of engineering or life science experience

Preferred Qualifications
  • Degree in Mechanical, Electrical, or BioMed Engineering

  • 5+ years of progressive experience as an engineer within the appropriate field of study

  • 2+ 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 applied 6 Sigma competency, specifically for root cause analysis methodology

  • Knowledge of 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

  • 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, so we 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 maximize 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

careers.amgen.com


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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