Dexcom Corporation is looking to solve the problem of improving human health by developing next-generation continuous glucose monitoring (CGM) systems, and the Senior Staff Systems Engineer will play a key role in defining the architectural roadmap and technical direction for these systems.
Requirements
- Mastery of the full Systems Engineering lifecycle, expertly applying the Systems V-model within a design control framework compliant with 21 CFR 820.30 and ISO 13485.
- Deep expertise in risk management methodologies (per ISO 14971) and can lead the development of system-level hazard analyses and FMEAs for complex electro-mechanical, software-driven medical device systems.
- Recognized authority and thought leader in leveraging AI agents to accelerate and de-risk the Systems Engineering lifecycle.
- Commanding knowledge of the entire product development lifecycle for regulated medical device systems and can strategically direct the use of tools like Jama Connect, Jira, TestRail, and GitHub to optimize program execution.
- Experience with FDA Class II or III medical devices, including direct involvement in submission support (e.g., 510(k), PMA).
- INCOSE Certified (CSEP) or Expert (ESEP) Systems Engineering Professional certification.
- Experience developing and implementing model-based Systems Engineering (MBSE) frameworks using tools like Cameo or Sparx EA.
Responsibilities
- Lead the definition and decomposition of System-level architecture for multiple, concurrent, next-generation CGM systems, from high-level concept to detailed subsystem interfaces.
- Architect and own the master Design Input requirements for complex product portfolios, ensuring robust alignment with the long-term product roadmap, enterprise architecture, and evolving regulatory landscapes.
- Pioneer and institutionalize the application of advanced AI agents for Systems Engineering, establishing best practices and prompt engineering frameworks for the entire Systems Engineering function to improve requirement quality, perform complex trade-off analysis, and automate traceability.
- Govern the end-to-end requirements traceability strategy across multiple product lines using tools like Jama Connect, ensuring architectural integrity and audit-readiness from user needs through verification and validation, in accordance with INCOSE Systems Engineering guidelines.
- Drive system-level integration activities, defining the strategy for continuous integration of both hardware (HW) and software (SW) components, and lead cross-functional teams in resolving complex architectural and integration challenges.
- Act as a primary technical mentor for a team of Systems Engineers, providing expert guidance on INCOSE-based Systems Engineering methodologies, complex problem-solving, and career development.
- Serve as the primary Systems Engineering technical lead on large-scale programs, adeptly managing competing priorities, technical ambiguity, and resource allocation to ensure successful project execution.
Other
- Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience.
- 0-5% travel required.
- Exceptional communicator and negotiator, capable of driving consensus among senior leadership and articulating complex architectural strategy and trade-offs to both technical and executive audiences.
- Demonstrated history of successfully leading system architecture for multiple complex, regulated products from concept to launch.
- Natural mentor and force multiplier, passionate about elevating the technical capabilities and Systems Engineering discipline across the entire engineering organization.
