Engineer - Technical Investigator
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's 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 CAPA's in support of identifying design solutions based on root cause and will also support cross functional ideation of design solutions.
What you will do
Let's do this. Let's 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 Amgen's 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 FMEA's 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
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.
Bachelor's degree and 2 years of engineering experience
Associate's degree and 6 years of engineering experience
High School diploma/GED and 8 years of engineering experience
- 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
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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.