Amgen Senior Engineer - Single-Use Auto-injector Platform Team in Thousand Oaks, California
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.
Senior Engineer - Single-Use Auto-injector Platform Team
What you will do
Let’s do this. Let’s change the world. In this vital role you will participate in the design, development and lifecycle management related activities for commercial drug delivery devices. This includes technical operations support for design control activities, contract manufacturing, failure investigation, leading and assessing design changes, development test procedures, scale-up and global launch, supplier development, and continuous improvement.
Scope includes mechanical and electro-mechanical delivery devices such as fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. Be part of a sustaining device engineering team that ensures design history files of the mechanical and electro-mechanical delivery devices are maintained. Participate in multi-functional teams, leading device design activities such as developing product improvements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
Responsible for applying all conventional aspects of the subject matter, functional area, and assignments. Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devise innovative ways to tackle problems.
Accountability of developing and maintaining technical records within design history file associated with assigned products.
Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
Lead system level root cause investigation, coordinate design improvements with development partners, critical thinking and implementation of design changes and improvements.
Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
Individual contributor with Leadership attributes to optimally represent device engineer within a large network/matrix organization.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineer professional we seek is a self-starter with these qualifications.
Master’s degree & 3 years of Engineering and/or Operations experience
Bachelor’s degree & 5 years of Engineering and/or Operations experience
Associate’s degree & 10 years of Engineering and/or Operations experience
High school diploma / GED & 12 years of Engineering and/or Operations experience
Bachelor's degree in engineering or other science-related field with at least 7 years of experience in operations/manufacturing environment
Experience in drug delivery, preferable combination product; or medical device industry and regulated work environment
Background in development and commercialization of medical devices, and knowledge of manufacturing processes
At a minimum familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
Strong understanding and experience in design controls, failure investigation, initiating and bringing sophisticated projects to conclusion
Excellent communication and technical writing skills
Ability to work independently and across functional teams
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.