Senior Device Engineer - Lifecycle Management
Core
Lead software lifecycle management for body contouring medical devices from production transfer to end of life, ensuring compliance with FDA and ISO regulations.
Role type
Senior Software Engineer (Lifecycle Management)
Builds
Embedded, Windows embedded, and desktop applications for medical device body contouring products.
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | infrastructure
Required skills
Embedded Windows programming (C#, .NET), structured software development, component-oriented architecture, software design patterns, event-driven application design, multi-threading, RS232/SPI/USB protocols, PID control algorithms, IEC 62304 lifecycle processes.
Preferred skills
Medical device development experience, Windows-based application development, PID control algorithm knowledge.
Technologies
C#, .NET, .NET Framework, Windows Embedded, RS232, SPI, USB
Responsibilities
Lead small-scale projects for on-time delivery; define functional requirements with cross-functional groups; perform data analysis to drive software/product quality improvements; design, develop, and support embedded and desktop applications; participate in software work product reviews; interface, integrate, troubleshoot, and debug software/hardware components; generate product development documentation (functional specs, design docs); execute manual/automated tests for verification and validation; design and validate software tools for verification and manufacturing; resolve software issues with verification, support, and manufacturing teams; drive process quality improvements; ensure compliance with FDA QSR, ISO13485, and Canadian Medical Device Regulations.
Seniority
Senior, hands-on IC with technical leadership