Amgen Device Engineer, D&FDPT Sustaining Engineering in Thousand Oaks, California
The Device Engineer will participate in the design development and lifecycle management related activities for commercial drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement. The incumbent shall have capability and competency of working with multiple project teams at same time, as well as ability to learn and self-develop expertise in the area of technology assignment.
Scope includes electro-mechanical delivery devices, such as; fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining engineering team that ensures successful device design transfer of these mechanical and electro-mechanical delivery devices. The position will focus on design/development engineering assignments focused on commercial mechanical, electro-mechanical systems, and fluid-mechanical systems.
Essential skills and Responsibilities:
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
Accountability of 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, strategic planning and execution 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 engineer within a large network/matrix organization
At a minimum familiar with the following standards and regulation:
Quality System Regulation - 21CFR820
Risk Management - ISO 14971
EU Medical Device requirements - Council Directive 93/42/EEC
The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.
Bachelor's degree and 2 years of related engineering experience
Associate's degree and 6 years of related engineering experience
High school diploma / GED and 8 years of related engineering experience
Mechanical or Electro-mechanical degree
Medical device industry experience and regulated work environment experience
Background in developing and commercialization of medical devices and knowledge of manufacturing processes
Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams
Excellent written and verbal communication skills
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.