Development Roles — Engineering, Construction & Verification
Development roles encompass the hands-on engineering team members who translate clinical and stakeholder needs into working, verified software. These six roles cover requirements analysis, solution architecture, type-safe coding, independent verification testing, automated build compilation, and user-facing technical documentation.
Core Engineering Team (6 Roles)
Every software release requires continuous collaboration between analysis, construction, and independent testing. Key acronyms used in this domain include Joint Application Design (JAD) workshops for requirements gathering, Software Requirements Specifications (SRS) for traceable design inputs, Architecture Decision Records (ADRs) for capturing technical tradeoffs, and Software Bill of Materials (SBOM) for tracking third-party dependencies and vulnerability provenance.
Systems Analyst
Translates high-level stakeholder needs into detailed, testable software requirements specifications and data flow models.
Primary Tasks
- Conduct Joint Application Design (JAD) workshops with clinicians and product managers
- Author Software Requirements Specifications (SRS) with bidirectional traceability
- Define clear acceptance criteria and interface boundary requirements
Key Artifacts
- Software Requirements Specification (SRS) PRODUCED
- User Needs Document CONSUMED
Skills & Competencies
Governance Responsibilities
- Ensure complete requirement coverage for ISO 13485 Cl. 7.3.3
- Manage requirement change impact analysis
Solutions Architect
Defines modular software architectures, service boundaries, and technical decisions to balance performance, security, and compliance.
Primary Tasks
- Author Architecture Decision Records (ADRs) for technical stack and design choices
- Define API schemas, integration contracts, and transactional boundaries
- Conduct system boundary threat modeling reviews per STRIDE methodology
Key Artifacts
- Architecture Decision Records (ADRs) PRODUCED
- System Architecture Specification PRODUCED
Skills & Competencies
Governance Responsibilities
- Maintain architectural integrity across development sprints
- Ensure architecture aligns with IEC 62304 safety classes
Software Developer
Constructs maintainable, clean, and type-safe code adhering to verified coding guidelines and unit test requirements.
Primary Tasks
- Write clean, modular code satisfying defined user stories and acceptance criteria
- Author comprehensive unit tests achieving target code coverage thresholds
- Participate in mandatory peer code reviews and resolve automated static analysis issues
Key Artifacts
- Production Source Code PRODUCED
- Automated Unit Test Suites PRODUCED
Skills & Competencies
Governance Responsibilities
- Adhere to ISO 27001 Control A.8.28 secure coding guidelines
- Ensure zero unreviewed code enters release branch
Software Test Engineer
Designs, automates, and executes integration and end-to-end test verification suites to validate functional specifications.
Primary Tasks
- Author Master Verification & Validation (V&V) test plans and test protocols
- Develop automated integration, regression, and performance test suites in CI/CD
- Record formal test execution evidence and manage anomaly/bug lifecycles
Key Artifacts
Skills & Competencies
Governance Responsibilities
- Validate software satisfies design inputs per ISO 13485 Cl. 7.3.6
- Provide independent verification sign-off
Build & Automation Engineer
Builds deterministic, immutable CI/CD compilation and verification pipelines that generate auditable release packages.
Primary Tasks
- Maintain automated containerized build pipelines with static code analysis checks
- Generate automated Software Bill of Materials (SBOM) on every release tag
- Ensure cryptographic checksum verification and artifact provenance retention
Key Artifacts
- Software Bill of Materials (SBOM) PRODUCED
- CI/CD Build & Verification Logs PRODUCED
Skills & Competencies
Governance Responsibilities
- Ensure build repeatability and reproducibility
- Enforce automated gate thresholds before release merging
Technical Writer & Documentation Specialist
Authors clear, plain-language user manuals, API documentation, developer guides, and compliance dossier references.
Primary Tasks
- Translate complex technical architectures into readable developer and user guides
- Maintain documentation site navigation manifests and cross-reference indices
- Review engineering prose for active voice, rhythm, and plain-language leads
Key Artifacts
- Technical Documentation & User Manuals PRODUCED
- Release Notes & Change Dossiers PRODUCED
Skills & Competencies
Governance Responsibilities
- Ensure documentation is clear, accurate, and Section 508 accessible
- Eliminate AI filler and unexplained acronyms
Community Discussion & Feedback
Attributed peer feedback and official Netspective architecture notes.