Amgen Senior Systems Engineer in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Senior Systems Engineer
What you will do
Let’s do this. Let’s change the world.
Analyze problems involving cross-disciplinary aspects of the product development process, and synthesize multiple solutions. Develop and exploit structured, efficient approaches to analysis and design to tackle complex engineering problems
Provide direction and support for the optimal design of complex, large-scale systems through consideration of the system as a whole, rather than individual elements of the system
Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program achievement
Conduct and review advanced computer simulations to design or test products
Prepare cost estimates on proposed major design products
Provide technical presentation support and consultation to marketing
Represent company unit in customer or field force contacts
Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs
Produce innovative technical solutions to customers
Prepare technical proposals for competitive bids
Develop potential applications to exploit new business opportunities
Collect and analyze information on competitor product performance
Use project planning and monitoring methods to ensure accurate completion
Originate and communicate concepts that could lead to new products
Review and approve completed design work
Actively contributes to identifying and pursuing new technological opportunities
This position is located in either Thousand Oaks, CA or Cambridge, MA, and involves 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.
Doctorate degree OR
Master’s degree and 3 years of Engineering and/or device development/manufacturing experience OR
Bachelor’s degree and 5 years of Engineering and/or device development/manufacturing experience OR
Associate’s degree and 10 years of Engineering and/or device development/manufacturing experience OR
High School diploma/GED and 12 years of Engineering and/or device development/manufacturing experience
10+ years of progressive experience as an engineer or scientist within the appropriate field of study
5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III
INCOSE certification or formal Systems Engineering training/certification
Demonstrated applied lean 6 Sigma competency
Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components
Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place, and current
Creative problem solver and solution developer when presented with conflicting requirements, business demands, and technical risks/issues
Demonstrated skills in eagerly identifying, facilitating, and driving closure of a product/program
Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product
Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering subject areas (Electrical, Mechanical, Software, etc.)
Experience in model-based design and UML and Small scale device assembly experience
Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams
Leadership ability for System Level Design and Testing (Verification and Validation testing of System-Level Performance)
Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)
Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.
Deep knowledge of Quality Management System, Quality Management Policy, and applicable laws and regulations as they apply to this job type/position
Familiar with the following standards:
US Good Manufacturing Practices – 21CFR820
Quality Management – ISO 13485
Risk Management – ISO 14971
EU Medical Device requirements – Council Directive 93/42/EEC
Medical Electrical Equipment – EN 60601
Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong interpersonal skills
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.
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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.