One Amgen Center Drive Thousand Oaks, California 91320 | Contract
The Senior Systems Engineer (SSE) leads activities to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The SSE drives 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.
- Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs
- Develop and document strong rational for test strategy, acceptance criteria, and results
- Work with Human Factors to ensure successful design validation from planning through report
- Develop and document robust tracing from design inputs through design outputs, verification, and validation
- Generate, review, and/or approve protocols, reports, and other DHF documentation ensuring robust documentation for regulatory agency submission
- Work with manufacturing and development teams on design transfer plans through execution
- 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.
- Bachelor’s degree & 5 years of directly related 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 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.
- Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance).
- 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), and 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.
- Strong interpersonal skills