Device Engineer
Location: Thousand Oaks
Posted on: June 23, 2025
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds toughest diseases. With our
focus on four therapeutic areas Oncology, Inflammation, General
Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on
the lives of patients as we research, manufacture, and deliver
innovative medicines to help people live longer, fuller happier
lives. Our award-winning culture is collaborative, innovative, and
science based. If you have a passion for challenges and the
opportunities that lay within them, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. Device Engineer What you will do Lets do
this! Lets change the world! The Development Engineer works as part
of a multi-disciplinary program team to build drug delivery
solutions which meet user requirements for Amgens portfolio of
therapeutic products from concept through commercial entry. The
individual advances technical programs, contributing to definition
of design requirements, identification and realization of technical
solutions, authoring of test methods and reports, and authoring of
technical analyses to advance programs. The successful candidate
establishes well-supported insights for concept and development
stage solutions to serve user needs and the needs of the pipeline
portfolio, using a range of program tools, design characterization
and verification methods, and design reviews. The candidate ensures
that the required performance and quality targets are satisfied and
helps identify and reduce technical risks on the program.
Responsibilities include but are not limited to: Planning and
implementing of drug delivery technical assessment tasks in support
of different therapeutic areas, including nephrology, bone health,
oncology, inflammation, and cardiovascular. Develop and exploit
structured, efficient approaches to analysis and design to tackle
complex engineering problems. Support investment analysis for drug
delivery technologies through demonstration that proposed solutions
meet user needs in service of Amgens product pipeline. Develop,
implement, and report technical analyses. Develop, implement, and
report verification methods and testing. Communicate effectively at
multiple organizational levels on project status, risks, issues,
and accomplishments. Successfully influence program outcomes.
Review completed design work with both internal and external design
partners. Use project planning and monitoring methods to ensure
accurate completion. Ensure compliance to Regulatory and Quality
requirements when generating design outputs and conducting
technical reviews. Contribute to and use advanced computer
simulations to support design & development efforts. Collaborate
with the commercial engineering organization to ensure adequate
sustainment and improvement of products throughout their lifecycle.
Facilitate development of solutions to critical business issues.
Effectively define objectives to enable effective metrics
generation and reporting. As part of the team working on device
platforms, ensure alignment to architecture to support variations
of the platform and system deliverable packages. What we expect of
you We are all different, yet we all use our unique contributions
to serve patients. The dynamic professional we seek is an
individual with these qualifications. Basic Qualifications: High
school diploma / GED and 8 years of Engineering and/or Medical
Device experience OR Associates degree and 6 years of Engineering
and/or Medical Device experience OR Bachelors degree and 2 years of
Engineering and/or Medical Device experience OR Masters degree
Preferred Qualifications: 2 years industry experience in
development of drug delivery technologies for therapeutic products
through commercial entry Working knowledge and familiarity with the
following: US Quality System Regulations for Medical Devices
(21CFR820) and International Quality Management Systems for Medical
Devices (ISO 13485). Drug-Device and Biologic-Device Combination
Product Requirements for cGMP. Physical test method development,
qualification, and validation. ISO 14971 and ISO 11608. Laboratory
equipment and techniques for drug delivery device development and
testing. Managing laboratory assets and test samples. CAD and 3D
printing of test fixtures and prototypes. Ability to read, analyze
and interpret general business periodicals, professional journals,
technical procedures, or governmental regulations Strong
problem-solving skills Capability to advance multiple projects in a
fast paced environment Strong oral and written communication
skills, decision making, presentation, and organization skills
Ability to collaborate and converse technically with diverse
partners such as hardware, software, systems, human factors,
materials science, quality, reliability engineering, domain experts
from commercial, clinical, molecular research, medical sciences,
regulatory, drug substance and drug product development
organizations Demonstrate ability to navigate ambiguity and provide
a structured problem-solving approach Organizational savvy and
presence to form effective relationships across functions Track
record of building or participating as a member of successful teams
Working knowledge of MS Office tools What you can expect of us As
we work to develop treatments that take care of others, we also
work to care for your professional and personal growth and
well-being. From our competitive benefits to our collaborative
culture, well support your journey every step of the way. The
expected annual salary range for this role in the U.S. (excluding
Puerto Rico) is posted. Actual salary will vary based on several
factors including but not limited to, relevant skills, experience,
and qualifications. In addition to the base salary, Amgen offers a
Total Rewards Plan, based on eligibility, comprising of health and
welfare plans for staff and eligible dependents, financial plans
with opportunities to save towards retirement or other goals,
work/life balance, and career development opportunities that may
include: A comprehensive employee benefits package, including a
Retirement and Savings Plan with generous company contributions,
group medical, dental and vision coverage, life and disability
insurance, and flexible spending accounts A discretionary annual
bonus program, or for field sales representatives, a sales-based
incentive plan Stock-based long-term incentives Award-winning
time-off plans Flexible work models, including remote and hybrid
work arrangements, where possible Apply now and make a lasting
impact with the Amgen team. careers.amgen.com In any materials you
submit, you may redact or remove age-identifying information such
as age, date of birth, or dates of school attendance or graduation.
You will not be penalized for redacting or removing this
information. 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 and live the Amgen values to continue
advancing science to serve patients. Together, we compete in the
fight against serious disease. 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,
disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided
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 accommodation.
Keywords: , Los Angeles , Device Engineer, Science, Research & Development , Thousand Oaks, California
