US – California – Thousand Oaks
The Senior Systems Engineer (SSE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The SSE drives the architecture, vision and design requirements for the product while balancing implementation complexity, risk, manufacturability, serviceability and reliability. The SSE understands and captures the user needs into system requirements and is responsible for the functional decomposition and allocation to subsystems. The SSE ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program. The SSE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
OR Master’s Degree & 3 years of Engineering experience
OR Bachelor’s Degree & 5 years of Engineering experience
OR Associate’s degree & 10 years of Engineering experience
OR High school diploma/GED & 12 years of Engineering experience
- 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.
- Provide direction and support for the optimal design of complex, large scale systems 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.
- 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.
- Utilize project planning and monitoring methods to ensure timely completion.
- Originate and communicate concepts which could lead to new products.
- Review and approve completed design work.
- Actively contributes to identifying and pursuing new technological opportunities.
- 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 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.
- Demonstrated broad 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: oUS Good Manufacturing Practices – 21CFR820 oQuality Management – ISO 13485 oRisk Management – ISO 14971 oEU Medical Device requirements – Council Directive 93/42/EEC oMedical 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.
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.
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