Amgen

Engineer - Technical Investigator

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 22, 2019
Ref
R-79192
Required Education
High School or equivalent
Position Type
Full time
Job Description

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.

We are seeking an Engineer in our Complaints Trending and Investigation group. This position is located in Thousand Oaks, CA. This position will report to our Senior 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. In addition to the below, this position will also support functional management initiatives and objectives as well as maintain close interaction with the engineering and quality functions to contribute to product improvement.

Job Responsibilities:
  • Perform 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.)
  • Perform technical investigations of Level 2 and 3 complaints associated with product design and / or usability issues, and support trend and consolidated investigations using data analytics
  • Conduct trend investigations through the review of manufacturing batch records, evaluation of returned product, product reserve sample inspections, and review of complaint histories and trends
  • Author final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
  • Participate in cross functional ideation of design solutions based on output of root cause analysis
  • Own Corrective/Preventive Actions (CAPA's) in support of identifying design solutions based on root cause and will also support cross functional ideation of design solutions
  • Conduct technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
  • Analyze 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


Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Engineering or Operations experience

OR

Associate's degree and 6 years of Engineering or Operations experience

OR

High School diploma/GED and 8 years of Engineering or Operations experience

Preferred Qualifications
  • Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed
  • 5 or more years of progressive experience as an engineer within the appropriate field of study
  • 2 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
  • 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
  • Knowledge of customer/patient use of mechanical and/or electromechanical products
  • Knowledge of manufacturing processes for packaged and/or distributed products


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 .