Sr. Engineer - Technical Investigator
Amgen is currently seeking a Sr. Engineer in our Complaints Trending and Investigation group. 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 - 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 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 owns CAPA's to support identifying 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.
- 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, 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 monthly 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 input to engineering for product improvements
- Coach and mentoring to junior engineers
- Support functional management initiatives and objectives
Master's degree and 3 years of Engineering or Operations experience
Bachelor's degree and 5 years of Engineering or Operations experience
Associate's degree and 10 years of Engineering or Operations experience
High School diploma/GED and 12 years of Engineering or Operations experience
- Master's 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
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.
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.