Amgen

Sr. Engineer - Technical Investigator

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-79193
Required Education
High School or equivalent
Position Type
Full time
Amgen focuses on areas of high unmet medical need and leverages 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.

Amgen is currently seeking a Sr. Engineer in our Complaints Trending and Investigation group. This position will report to our Sr Manager of Complaints Trending and Investigation. In support of Amgen's mission to serve patients, the Complaints Trending and Investigation group at Amgen is 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 - 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 will understand customer / patient use of Amgen's packaged and/or distributed mechanical and/or electromechanical product as well as understand manufacturing processes for Amgen's packaged and/or distributed products. The position will own CAPA's in support of identifying design solutions based on root cause and will also participate in cross functional ideation of design solutions. The Sr. Engineer - Technical Investigator 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 tools and processes (Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines may be used)
  • Lead trend investigations through the review of manufacturing batch records
  • Lead evaluation of returned product, product reserve sample inspections, 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
  • Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
  • Lead cross functional ideation of design solutions based on output of root cause analysis
  • Develop and perform relational data analytics in support of investigations
  • Perform 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 FMEA's or Fault Tree Analysis
  • Provide input to management for trend and failure investigation process improvement
  • Provide input to engineering for product improvements
  • Provide technical coaching and mentoring to junior engineers
  • Support functional management initiatives and objectives


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Engineering or Operations experience

OR

Bachelor's degree and 5 years of Engineering or Operations experience

OR

Associate's degree and 10 years of Engineering or Operations experience

OR

High School diploma/GED and 12 years of Engineering or Operations experience

Preferred Qualifications
  • Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed
  • 10 or more years of progressive experience as an engineer within the appropriate field of study
  • 5 or more 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
  • Demonstrated experience with mechanical and/or electromechanical medical devices
  • Demonstrated applied 6 Sigma competency, 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


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 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 .

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.