Amgen Engineer (Advanced Device Technologies and Innovation) in Thousand Oaks, California

Amgen is seeking a Sr. Engineer at its main headquarters in Thousand Oaks, CA to join the Advanced Device Technologies and Innovation team. As a member of the Advanced Device Technologies and Innovation organization, the Engineers' work will focus on advancing a range of device technologies from traditional to novel as candidates for Amgen's combination products portfolio. The scope of traditional technologies would include devices such as; fluid transfer devices, pen injectors, and micro-infuser delivery pump systems. The qualified candidate will ensure successful entry of these technologies into short-cycle robust device development. The Engineer will work closely with cross-functional team members and business stakeholders.

Position Responsibilities include:

Generate brand-specific drug delivery device technology roadmaps for new product introductions and lifecycle management

Serve as first and primary contact between product teams and Amgen's Device and Final Drug Product Technologies Organization

Responsible for engineering aspects of technology recommendations to brand teams

Communication of brand technology strategy and coordination within the Organization

Assist with identification and generation of inputs for strategic planning within the organization

Accumulate and review information on requisite design space for future device innovations

Assist with knowledge management advances to help communicate Device and Final Drug Product capabilities to the organization

Work with Amgen's partners in the evaluation of device, diagnostics, and ancillary technologies

Up to 20% domestic and/or international travel

Basic Qualifications:

Master's Degree

OR

Bachelor's Degree and 2 years of Engineering experience

OR

Associate's degree and 6 years of Engineering experience

OR

High school diploma/GED and 8 years of Engineering experience

Preferred Qualifications:

BS in Biomedical, Mechanical, Materials, Electrical, Systems Engineering or similar

2+ years' current experience in medical device / combination products development from concept through clinical introduction and commercialization

Experience in design and development of drug delivery devices for Europe and/or US (FDA/PMA/510k) submissions

Familiarity with intellectual property review and generation

Experience in database management or other IS (IT) functions

Experience working with cross-functional product teams

Experience interacting with external design, development, and manufacturing partners

Sufficient grasp of quality, risk management, regulatory, marketing, and clinical considerations to guide programs

Experience with technical evaluation of Amgen relevant technologies

Core design skills including: CAD, drawing development and standards, material selection, hand calculations and computational analysis, tolerance methods, Design for Six Sigma, Design for Manufacture

Working knowledge of strategic business considerations

Examples exhibiting decision making and organizational skills

Strong written and verbal skills in communication of technical material

Strong problem solving and risk management skills

Familiarity with the following standards: Quality System Regulation - 21CFR820 | Quality Management - ISO 13485 | Risk Management - ISO 14971 | EU Medical Device requirements - Council Directive 93/42/EEC | Medical Electrical Equipment - EN 60601

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

Capable of working on multiple projects in a deadline driven environment

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.