Management Roles — Project & Stakeholder Governance
Management roles provide operational leadership, schedule governance, resource allocation, and formal regulatory oversight. These two roles ensure engineering iterations align with executive business goals and medical device quality plans.
Governance & Executive Authority (2 Roles)
Management roles establish organizational commitment, schedule milestones, and authorize budget allocation. These roles ensure compliance with FDA 21 CFR §820.30 and ISO 13485 Clause 5 management review requirements. Key acronyms include Design History Files (DHF) for audit readiness, Statements of Work (SOW), and Corrective and Preventive Actions (CAPA) for systematic problem remediation.
Technical Project Manager
Governs project schedules, sprint allocations, cross-discipline milestone reviews, and formal design control phase gates.
Primary Tasks
- Plan sprint cycles, manage milestone delivery schedules, and remove team blockers
- Organize formal phase-gate review meetings with cross-discipline stakeholders
- Maintain project risk registers and resource allocation forecasts
Key Artifacts
Skills & Competencies
Governance Responsibilities
- Ensure phase gate sign-offs occur before transitioning SDLC phases
- Maintain alignment with ISO 13485 Cl. 7.3.2
Project Stakeholder
Provides strategic business context, domain validation, executive sponsorship, and formal acceptance of deliverables.
Primary Tasks
- Define core business requirements, regulatory targets, and clinical success criteria
- Review sprint demonstrations and provide timely strategic feedback
- Participate in formal milestone acceptance gates and project authorization reviews
Key Artifacts
- Business Case & Value Realization Goals PRODUCED
- Formal Acceptance Sign-Off PRODUCED
Skills & Competencies
Governance Responsibilities
- Authorize project budget and milestone baseline scope
- Provide executive representation under ISO 13485 Cl. 5.5.2
Community Discussion & Feedback
Attributed peer feedback and official Netspective architecture notes.