Device Engineer
Device Engineer
US - California - Thousand Oaks Apply NowJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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
Let’s do this! Let’s 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 Amgen’s 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 Amgen’s 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
Associate’s degree and 6 years of Engineering and/or Medical Device experience OR
Bachelor’s degree and 2 years of Engineering and/or Medical Device experience OR
Master’s 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, we’ll 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
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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.
