Device Engineer
Device Engineer
US - California - Thousand Oaks APLICAR AHORAJoin 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!
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
Associate’s degree and 6 years of Engineering and/or Operations experience OR
Bachelor’s Degree and 2 years of Engineering and/or Operations experience OR
Master’s 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, 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
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.
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