Job ID: R-104240 Location: Thousand Oaks, CA, US 91360
Device Engineer, Final Product Technologies, Commercial Product Engineering
The CPE Device Engineer is essential part of our team in the design development and lifecycle management related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement.
The life changing products that this position will be contributing to include mechanical and electro-mechanical delivery devices, such as: fluid transfer devices, automatic pen injectors, reusable automatic injectors, or micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The Engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
The Device Engineer is responsible to apply all conventional aspects of the subject matter, functional area, and their assignments. They plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard engineering techniques, procedures and criteria and devises new approaches to problems encountered.
Accountability of maintaining technical records within design history file associated with assigned products
Support system level design, development, and V&V work for commercial lifecycle management changes or in support of new project development
Develop test methods, generate and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
Serve as support engineer for system level root cause investigation. Coordinate design improvements with development partners, long term planning strategy 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 effectively represent device engineering within a large network/matrix organization
The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.
Bachelor's Degree and 2 years of Engineering and/or Operations experience
Associate's degree and 4 years of Engineering and/or Operations experience
High school diploma/GED and 6 years of Engineering and/or Operations experience
A Master's or Bachelor's degree in Biomedical / Mechanical / Electrical or related Engineering field and 3+ years of related engineering experience
Medical device industry experience and regulated work environment experience
A background in development and commercialization of medical devices and knowledge of manufacturing processes
Understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion
Familiar with the following standards and regulations: Quality System Regulation - 21CFR820
Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC
Ability to work independently and across functional teams
Excellent (technical) written and verbal communication
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.
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.PI123693625