Lead Systems Architect
Core
Lead systems engineering for the Chronic Disease Management (CDM) R&D Program Portfolio, defining architecture, managing lifecycle, and ensuring technical functionality of medical device products.
Role type
Senior Systems Architect (Medical Devices)
Builds
Chronic Disease Management product portfolio and associated quality systems
Domain
Medical Devices / Ophthalmology / Quality Assurance
Deliverable
production ML models | product features | infrastructure
Required skills
Systems engineering leadership, system architecture and modular design, specification definition and analysis, risk identification and mitigation, system integration, verification and validation, quality system design and implementation, knowledge of ISO 13485 and 21 CFR Part 820, project management
Preferred skills
Enterprise IT systems (SAP, CRM, Agile, SharePoint), statistical analysis, medical electronic instruments, image processing, modeling and simulation tools (MATLAB, Mathematica), global standards influence
Technologies
SAP, CRM, Agile, SharePoint, MATLAB, Mathematica
Responsibilities
Direct systems engineering activities across the CDM product portfolio, define and document system specifications and tradeoffs, lead system integration across specialist areas, plan and conduct testing and verification of product features, create system definitions and technical product specifications, develop design and documentation standards, collaborate with cross-functional teams to translate business needs into technology solutions, set requirements for the technology roadmap
Seniority
Senior, hands-on IC with leadership responsibilities