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Specialist Roles

Compliance, security, operations, and UX/design roles in NUP

NUP defines specialized roles to address the unique requirements of regulated industries, security-critical systems, and user-centered design. These roles extend the core development team with domain expertise essential for compliance and operational excellence.

Specialist Role Categories

Specialist Role Categories


Compliance & Security Roles

Security Advisor

The Security Advisor serves as the first point of contact for security support and additional resources. This person serves as the security advisor for the project.

Primary Responsibilities:

  • Advise on security requirements and design decisions
  • Review security aspects of architecture and implementation
  • Identify security risks and mitigation strategies
  • Coordinate with security testing team
  • Ensure security best practices are followed

Tasks Performed:

  • Design the Solution (security aspects)
  • Find and Outline Requirements (security requirements)
  • Implement Developer Tests (security tests)
  • Implement the Solution (security controls)
  • Plan Project (security planning)

Artifacts Modified:

  • Build
  • Design
  • Developer Test
  • Glossary
  • Implementation
  • Project Plan
  • Risk List
  • Supporting Requirements Specification
  • Use Case
  • Use-Case Model
  • Work Items List

When This Role is Needed:

  • Projects with sensitive data
  • Systems facing external threats
  • Regulated industry applications
  • Internet-facing applications

Security Tester

The Security Tester conducts security testing and vulnerability assessment to identify security weaknesses before deployment.

Primary Responsibilities:

  • Perform penetration testing
  • Conduct vulnerability assessments
  • Test authentication and authorization
  • Verify security controls
  • Report security findings

Key Activities:

ActivityDescription
Vulnerability ScanningAutomated scans for known vulnerabilities
Penetration TestingManual testing to find security gaps
Code ReviewSecurity-focused code analysis
Configuration ReviewSecurity of system configurations
Compliance VerificationTest against security standards

Safety Assurance Analyst

The Safety Assurance Analyst ensures that safety requirements are identified, documented, and properly addressed throughout the development lifecycle.

Primary Responsibilities:

  • Identify safety hazards and risks
  • Define safety requirements
  • Review designs for safety compliance
  • Ensure safety testing is adequate
  • Maintain safety documentation

Applicable Domains:

  • Medical devices and healthcare
  • Automotive systems
  • Industrial control systems
  • Aviation and aerospace
  • Critical infrastructure

Safety Tester

The Safety Tester validates that safety-critical functionality meets requirements and does not introduce unacceptable risks.

Primary Responsibilities:

  • Execute safety test cases
  • Verify hazard mitigations
  • Test failure modes and recovery
  • Document safety test results
  • Report safety anomalies

Testing Focus Areas:

  • Failure mode testing
  • Boundary condition testing
  • Recovery testing
  • Error handling verification
  • System degradation testing

Information Assurance Analyst

The Information Assurance Analyst ensures that information security controls are properly implemented to protect data confidentiality, integrity, and availability.

Primary Responsibilities:

  • Define information security requirements
  • Review security architecture
  • Assess compliance with security standards
  • Monitor security controls effectiveness
  • Coordinate security incident response

Security Domains:

DomainFocus
ConfidentialityData protection, access control
IntegrityData accuracy, change control
AvailabilitySystem uptime, disaster recovery
AuthenticationIdentity verification
AuthorizationAccess permissions
AuditLogging, monitoring, forensics

HIPAA Compliance Officer

The HIPAA Compliance Officer is responsible for ensuring that all HIPAA requirements are met and that periodic audits are performed to verify compliance.

Primary Responsibilities:

  • Ensure HIPAA Privacy Rule compliance
  • Ensure HIPAA Security Rule compliance
  • Conduct periodic compliance audits
  • Manage HIPAA training programs
  • Respond to compliance incidents

HIPAA Focus Areas:

RuleRequirements
Privacy RulePHI use and disclosure controls
Security RuleAdministrative, physical, technical safeguards
Breach NotificationIncident response and reporting
EnforcementPenalties and compliance verification

Related Guidelines:

  • HIPAA Compliance guidelines
  • PHI handling procedures
  • Security incident response

Regulatory Compliance Assurance (RCA) Analyst

The RCA Analyst ensures that regulatory requirements are properly identified, documented, and addressed in the system design and implementation.

Primary Responsibilities:

  • Identify applicable regulations
  • Define compliance requirements
  • Review designs for regulatory compliance
  • Track compliance artifacts
  • Support audit activities

Compliance Frameworks:

FrameworkDomain
HIPAAHealthcare
PCI-DSSPayment cards
SOXFinancial reporting
FISMAFederal systems
GLBAFinancial services
GDPREU data protection
FDAMedical devices

Regulatory Compliance Verification (RCV)

The RCV role verifies that compliance requirements have been properly implemented and documented.

Primary Responsibilities:

  • Verify compliance implementation
  • Review compliance documentation
  • Conduct compliance testing
  • Prepare audit evidence
  • Track compliance gaps

Verification Activities:

ActivityPurpose
Control TestingVerify controls are implemented
Documentation ReviewEnsure required docs exist
Evidence CollectionGather audit evidence
Gap AnalysisIdentify compliance gaps
Remediation TrackingMonitor gap closure

Reliability Engineer

The Reliability Engineer ensures system reliability through design review, testing, and operational practices.

Primary Responsibilities:

  • Define reliability requirements
  • Review designs for reliability
  • Implement reliability testing
  • Monitor system reliability metrics
  • Drive reliability improvements

Tasks Performed:

  • Design the Solution
  • Find and Outline Requirements
  • Implement the Solution
  • Run Developer Tests

Artifacts Modified:

  • Build
  • Design
  • Glossary
  • Implementation
  • Supporting Requirements Specification
  • Test Log
  • Use Case
  • Use-Case Model
  • Work Items List

Reliability Focus Areas:

AreaActivities
AvailabilityUptime targets, redundancy
Fault ToleranceGraceful degradation
RecoveryBackup, disaster recovery
ScalabilityLoad handling, performance
MonitoringHealth checks, alerting

Operations & Infrastructure Roles

Operations Engineer

The Operations Engineer ensures the setting up of development, test, and production environments with help from the development teams.

Primary Responsibilities:

  • Set up development environments
  • Configure test environments
  • Prepare production infrastructure
  • Automate deployment processes
  • Support DevOps practices

Primary Task:

  • Ensure the involvement of the DevOps Team

Environment Types:

EnvironmentPurpose
DevelopmentDeveloper workstations, local testing
IntegrationContinuous integration, automated tests
StagingPre-production validation
ProductionLive system

DevOps Activities:

DevOps Pipeline


Release Engineer

The Release Engineer manages build, release, and deployment processes to ensure consistent and reliable software delivery.

Primary Responsibilities:

  • Manage build systems and processes
  • Coordinate release activities
  • Maintain deployment automation
  • Ensure release quality gates
  • Document release procedures

Release Management Activities:

ActivityDescription
Build ManagementCI/CD pipeline maintenance
Version ControlBranching and tagging strategies
Artifact ManagementPackage and store releases
DeploymentAutomated deployment execution
RollbackRevert failed releases

UX/Design Roles

Interaction Designer

The Interaction Designer designs how users interact with the system, focusing on workflows, navigation, and user tasks.

Primary Responsibilities:

  • Design user workflows
  • Create interaction patterns
  • Define navigation structures
  • Prototype user interfaces
  • Validate designs with users

Deliverables:

  • Wireframes
  • Interaction flows
  • User journey maps
  • Prototype designs
  • Interaction specifications

Usability Designer

The Usability Designer ensures that products are easy to use by applying usability principles and conducting user research.

Primary Responsibilities:

  • Conduct usability testing
  • Perform user research
  • Define usability requirements
  • Review designs for usability
  • Recommend usability improvements

Usability Methods:

MethodPurpose
Usability TestingObserve users completing tasks
Heuristic EvaluationExpert review against principles
A/B TestingCompare design alternatives
Survey/InterviewGather user feedback
Analytics ReviewAnalyze usage patterns

User Interface Designer

The User Interface Designer creates the visual design of user interfaces, including layouts, colors, typography, and visual elements.

Primary Responsibilities:

  • Create visual designs
  • Define style guides
  • Design UI components
  • Ensure visual consistency
  • Maintain design systems

Deliverables:

  • Visual designs (mockups)
  • Style guides
  • Component libraries
  • Design specifications
  • Asset files

Sensory Designer

The Sensory Designer addresses multi-sensory aspects of user experience, including visual, auditory, and haptic feedback.

Primary Responsibilities:

  • Design multi-sensory experiences
  • Define audio feedback
  • Design haptic responses
  • Ensure accessibility
  • Consider sensory limitations

Sensory Considerations:

SenseDesign Elements
VisualColors, contrast, motion
AuditorySounds, alerts, voice
HapticVibration, touch feedback
AccessibilityAlternative modalities

Role Involvement by Phase

Compliance & Security Roles

RoleStrategyEnvisionInceptionElaborationConstructionTransitionProduction
Security AdvisorCAAAAAC
Security Tester-CCAAAC
Safety AnalystCAAAAAC
Safety Tester-CCAAAC
HIPAA OfficerAAACCAA
RCA AnalystAAAACAC
RCV-CCAAAA

Legend: A = Active, C = Consulting, - = Not typically involved

Operations Roles

RoleStrategyEnvisionInceptionElaborationConstructionTransitionProduction
Operations Eng.CCAAAAA
Release Eng.-CCAAAA
Reliability Eng.CCAAAAA

UX/Design Roles

RoleStrategyEnvisionInceptionElaborationConstructionTransitionProduction
Interaction DesignCAAACC-
Usability DesignCCAAAAC
UI Designer-CAAAC-
Sensory Designer-CCAAC-

Team Structure with Specialists

Small Team (with compliance needs)

Small Team with Compliance

Medium Team (regulated industry)

Medium Team - Regulated Industry

Large Team (enterprise, heavily regulated)

Large Team - Enterprise


Best Practices

Compliance Roles

  • Engage early in the project lifecycle
  • Document compliance requirements explicitly
  • Track compliance evidence continuously
  • Plan for audit readiness from the start

Security Roles

  • Security by design, not afterthought
  • Conduct threat modeling early
  • Test security throughout development
  • Monitor security in production

Operations Roles

  • Automate everything possible
  • Plan for failure and recovery
  • Monitor proactively
  • Document runbooks

UX/Design Roles

  • Involve users early and often
  • Iterate on designs based on feedback
  • Test with real users
  • Maintain design consistency

Compliance

This section fulfills ISO 13485 requirements for responsibility and authority (5.5.1), competence (6.2), and risk management (7.1), and ISO 27001 requirements for security roles (A.5.2), compliance responsibilities (A.5.31), and information security risk management (6.1).

View full compliance matrix

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