Sr. Engineer - Technical Investigator

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr Engineer - Technical Investigator

Live

What you will do

Lets do this! Lets change the world!

Amgen is currently seeking a Sr. Engineer in our Complaints Trend and Investigation group. In support of Amgens mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices to ensure supply and to optimize the patient experience.

The Sr. Engineer conducts technical investigations of complaints associated with product design and/ or usability issues and conducts trend and consolidated investigations using data analytics. Understands customer/ patient use of Amgens packaged and/or distributed mechanical and/or electromechanical product as well as understand manufacturing processes for these products. The Sr. Engineer owns CAPAs to support identification of 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.

Job responsibilities:

• 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 methods

• 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 FMEAs or Fault Tree Analysis. (Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines 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, as well as generation of reports

• 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

• Coach and mentoring to junior engineers

• 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

Masters degree and 3 years of Engineering, medical/biopharma development or Operations experience OR

Bachelors degree and 5 years of Engineering, medical/biopharma development or Operations experience OR

Associates degree and 10 years of Engineering, medical/biopharma development or Operations experience OR

High School diploma/GED and 12 years of Engineering, medical/biopharma development or Operations experience

Preferred Qualifications:

• Masters Degree in 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

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.

The annual base salary range for this opportunity in the U.S. is $111,913 - $132,048.

In addition to the base salary, 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

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.

Apply now

for a career that defies imagination

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

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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 cancers, 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.