Amgen

Systems Engineer

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 23, 2022
Ref
R-142371
Required Education
High School or equivalent
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Systems Engineer

Live

What you will do

Lets do this. Lets change the world. In this vital role, you will work as part of multi-functional program teams to deliver the technical content, performance, intellectual property, and quality deliverables of a combination product development program

  • 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 sophisticated engineering problems.
  • On product core teams, represent the best practices of systems engineering through consideration of the system as a whole, rather than individual building blocks 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 achievements.
  • Provide technical presentations in functional and multi-functional settings.
  • Represent Amgen and function at customer or field contacts.
  • Collect and analyze information on competitor product performance.
  • Apply project planning and monitoring methods to ensure well-time completion.
  • Create own, review, and approve others completed design control deliverables.
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a detailed oriented person with these qualifications.

Basic Qualifications:

  • Masters degree OR
  • Bachelors degree and 2 years of engineering experience OR
  • Associates degree and 6 years of engineering experience OR
  • High school diploma / GED and 8 years of engineering experience

Preferred Qualifications:

  • 5+ years of sophisticated experience as an engineer or scientist within the appropriate field of study
  • Creative problem solver and solution developer when presented with conflicting requirements, business demands, and technical risks/issues.
  • Established skills in diligently identifying, facilitating, and driving closure of a product/program.
  • Demonstrated ability to work with the technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.
  • Exposure to HW/SW/Systems design and technical depth in one or more engineering fields (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 Systems, 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
Thrive

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 maximize 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now

for a career that defies imagination

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

careers.amgen.com
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.