Lead systems design and development across cloud and mobile platforms for Lingo, Abbott's biosensing technology. Define architecture, manage product risks and requirements, support verification and validation, and maintain regulatory compliance and design documentation in a medical device environment.
Responsibilities
- Define software system architecture, safety classification, and system design.
- Create and maintain interface control documentation for hardware and data system integration.
- Lead product risk management, hazard identification, mitigations, and traceability.
- Coordinate verification and validation planning, execution, and system test documentation.
- Maintain design history files, requirements traceability, and regulatory compliance documentation.
- Support defect analysis, audits, regulatory submissions, software validation, configuration management, and change control.
Required Skills
- Systems architecture
- Software systems engineering
- Io
- T systems
- Cloud platforms
- Mobile platforms
- Requirements definition and management
- Interface control documentation
- Risk management
- Verification and validation
- Medical device regulatory standards
