Device Engineer

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!

Amgen is currently seeking a Device Engineer in our Combination Product Development and Lifecycle management group. The Device Engineer will participate in the design development and lifecycle management related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.

Scope includes Prefilled Syringes and mechanical delivery devices. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

Essential skills and Responsibilities:

• To support technical teams in the successful testing, commercial development and lifecycle management of drug delivery devices. Devices might range from Prefilled syringes (PFS) to Mechanical Injectors.

• The engineer will participate in multi-functional teams, leading device testing activities, analytical failure analysis and implementing test solutions, assessment of proposed changes and writing of testing protocols and reports. Test activities will also include engineering, characterization, and GMP verification testing. The position requires proficiency in developing test protocols, test execution, technical report authorship, reporting of results to senior leadership, Good Documentation Practices and statistical analysis.

• This engineer will interact with global and multi-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups.

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.

• Author design control and technical documents including test/verification plans, test protocols, test reports, engineering assessments, design outputs, and technical recommendations

• Hands on testing of prefilled syringes, including the safe operation of test equipment and devices containing sharps (syringes)

• Develop verification testing strategy to including differentiation between platform and combination product testing to ensure minimum duplication and maximum efficiency when commercializing multiple programs

• Accountability of developing and maintaining technical records within design history file associated with assigned products.

• Ensure tests methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors

• Prepare and provide communications to leadership in support of recommendations and assessments

• Collaborate with and support manufacturing sites on design/fabrication of assembly and labeling equipment

• Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and implementation of design changes and improvements.

• Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.

This position will be located in Thousand Oaks, CA and with up to 10% domestic and international travel.

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 Operations experience OR

• Associates degree and 6 years of Engineering and/or Operations experience OR

• Bachelors Degree and 2 years of Engineering and/or Operations experience OR

• Masters Degree

Preferred Qualifications:

• Experience with Final Drug Product and/or Drug Product

• Experience with investigations and quality records

• Laboratory and electronic lab notebook experience

• Experience in combination product industry and regulated work environment

• Background in development and commercialization of medical devices, and knowledge of manufacturing processes

• Experience with Good Documentation Practices, GMP and strong technical writing (protocols, reports, etc.)

• Ability to partner cross-functionally and communicate effectively

• Understanding of the following standards and regulations: Quality System Regulation 21CFR820; Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices ISO 14971; EU Medical Device Regulation 2017/745

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.