The Systems Engineer (SE) works as part of cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of a combination product development program. The SE understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied, identifies technical risks and assists risk retirement activities on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
Master's Degree & 2 year of Engineering experience
Bachelor's Degree & 3 years of Engineering experience
Associate degree & 7 years of Engineering experience
High school diploma/GED & 9 years of Engineering experience
Responsibilities include but are not limited to:
- Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems.
- On product core teams, represent the best practices of systems engineering through consideration of the system as a whole, rather than individual components 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 milestones.
- Provide technical presentations at functional and cross functional settings.
- Represent Amgen and function at customer or field contacts.
- Collect and analyze information on competitor product performance.
- Utilize project planning and monitoring methods to ensure timely completion.
- Create own, review and approve others' completed design control deliverables.
- 5+ years of progressive 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.
- Demonstrated skills in proactively 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.
- Exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (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.
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.