Role overview
Guide Agile delivery for a team building regulated medical device software. The role combines sprint facilitation and delivery coordination with active oversight of risks, dependencies, release evidence, and team practices.
Responsibilities
- Facilitate team planning and delivery, helping maintain alignment with agreed readiness and completion criteria.
- Track program risks, assumptions, issues, and dependencies; surface items that could affect delivery or release.
- Coordinate with the Release Manager on documentation readiness for team deliverables.
- Monitor delivery and release indicators, and report progress using relevant KPIs.
- Support audit and corrective and preventive action activities, and promote continuous improvement.
- Assess whether risk-management findings, verification evidence, or other quality artifacts affect release readiness.
Requirements
- Experience as a Scrum Master on a mobile or cloud product in a regulated environment.
- Practical knowledge of medical device software regulations, quality systems, Design Controls, and Design History File content.
- Familiarity with verification and validation evidence, design verification, and medical device risk artifacts such as failure mode and hazard analyses.
- Experience managing risk, assumption, issue, and dependency tracking as a program practice, and participating in audits and corrective actions.
- Ability to define and report delivery or release KPIs and partner with release management on documentation.
- Strong command of team-level Definition of Ready and Definition of Done, including developing, refining, and applying them.
- Working knowledge of a requirements and traceability tool such as Polarion and of Smartsheet.
Nice to have
- Scrum Master certification, such as CSM, PSM, or a SAFe Scrum Master credential.