Required Core Technical Skills (.NET Ecosystem)
- C# proficiency – Primary language for .NET development
- ASP.NET / ASP.NET Core – For building scalable web applications and APIs
- Entity Framework / LINQ – ORM and data querying
- SQL Server / NoSQL / Oracle – Database design and management
- Visual Studio & Git – IDE and version control
- RESTful API development – For device communication and integration
- Client-side tech – HTML, CSS, JavaScript, and frameworks like Angular or React (for UI)
Required Medical Device-Specific Skills
- Understanding of IEC 62304 – Software lifecycle processes for medical devices
- Familiarity with FDA regulations – Especially 21 CFR Part 11 for electronic records
- Risk management (ISO 14971) – Identifying and mitigating software-related risks
- Validation & Verification (V&V) – Writing test protocols and ensuring compliance
- Traceability matrices – Mapping requirements to code and tests
Required System & Integration Knowledge
- Embedded systems communication – Serial, USB, Bluetooth, or TCP/IP protocols
- HL7 / DICOM standards – For interoperability in healthcare systems
- Cloud integration – Azure or AWS for remote device data handling
- Cybersecurity awareness – Protecting patient data and device integrity
Soft Skills & Traits
- Systems thinking– Understanding how software fits into the broader device ecosystem
- Collaboration & flexibility – Working with cross-functional teams (QA, RA, hardware)
- Attention to detail– Crucial for regulatory compliance and safety-critical code
- Curiosity & accountability – Willingness to learn, take risks, and own outcomes