Software Architect
Experience 8–15 years
Job Summary
We're seeking a seasoned Software Architect to design and govern the architecture for our medical device software stack. You'll own the end-to-end architecture for C++ core, Qt-based UI, and device integration, ensuring safety, reliability, performance, and regulatory compliance in a healthcare environment.
- Define and drive the software architecture for C++ core modules, Qt UI, and device interfaces.
- Translate clinical, regulatory, and product requirements into scalable, maintainable architecture and roadmaps.
- Establish design patterns, componentization, interfaces, and data models; govern architectural decisions and trade-offs.
- Lead architectural reviews, ensure traceability to requirements, risk management, and safety-related design activities.
- Ensure compliance with medical device regulations (e.g., ISO 13485, IEC 60601-1, MDR/IVDR per region) and software lifecycle processes.
- Oversee safety, reliability, performance, cybersecurity, and fail-safe behavior across the stack.
- Drive architecture for hardware-software integration, drivers, middleware, real-time constraints, and platform portability.
- Mentor software engineers and ensure effective code quality, reviews, and design documentation.
- Collaborate with UX/UI, QA, regulatory, hardware, and clinical teams to align architecture with user needs and validation plans.
- Define and maintain architecture artifacts: high-level designs, component diagrams, interfaces, non-functional requirements (NFRs), and API specs.
- Manage technical risk registers and mitigation plans; propose reuse strategies and platformization where feasible.
Required Qualifications
- Bachelor's or Master's degree in Computer Science, Software Engineering, or related field.
- 8+ years of professional software engineering experience in C++ with strong object-oriented and design-pattern skills.
- 5+ years in software architecture/leadership roles, preferably in medical device or regulated healthcare environments.
- Proven experience with Qt (widgets or QML) for complex, user-centric desktop or embedded UI.
- Deep understanding of cross-platform development, performance optimization, memory management, and real-time considerations.
- Familiarity with hardware/firmware integration, device drivers, and IPC mechanisms.
- Solid knowledge of software development life cycle in regulated environments (requirements, design, implementation, verification, validation, change control).
- Experience with risk management processes (ISO 14971) and software safety concepts.
- Strong communication and collaboration skills; proven ability to influence across disciplines.
Nice-to-Haves
- Experience with embedded Linux, real-time OS, or bare-metal environments.
- Knowledge of cybersecurity standards and secure-by-design practices for medical devices.
- Experience with formal methods or model-based design (UML, SysML, architecture frameworks).
- Fluency in additional languages used in healthcare (e.g., German, French) or global regulatory knowledge.
- Prior role in a compliance/audit context and successful regulatory submissions.
Technical Skills
- C++ (C++11/14/17/20), modern idioms, templates, RAII, STL, move semantics.
- Qt framework: widgets, signals/slots, QML, model-view patterns, MVC/MVVM.
- Software architecture styles: layered, component-based, event-driven, service-oriented.
- APIs, SDKs, middleware, and hardware abstraction layers.
- Architecture modeling: UML/SysML, architecture decision records (ADRs).
- Version control, CI/CD, test automation, and code quality tooling.
- Knowledge of standards: IEC 62304, ISO 62366 (use/error), ISO 14971, ISO 13485.
Responsibilities (Regulatory and Quality)
- Ensure design documentation supports regulatory submissions and audits.
- Maintain requirements traceability and evidence for verification/validation.
- Collaborate with cybersecurity, safety, and quality teams to meet regulatory expectations.
