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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Agile methodologies, particularly in facilitating teams and managing sprint execution within regulated medical device software environments. Proficient in risk management, compliance with regulatory standards, and defining Key Performance Indicators for effective delivery.
Highest-signal resume keywords
Agile FacilitationRegulatory Standards KnowledgeRisk Management ArtifactsKey Performance Indicators ReportingScrum Master Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Sprint Execution ManagementDesign History File ContentDesign Verification ActivitiesRisks, Assumptions, Issues, and Dependencies TrackingContinuous Improvement Support
Soft Skills
Team AccountabilityDelivery ExcellenceCollaboration
Tools & Technologies
PolarionSmartsheet
Certifications & Qualifications
Certified Scrum MasterProfessional Scrum MasterScaled Agile Framework Scrum Master
Industry Keywords
Medical Device SoftwareQuality SystemsDesign ControlsDesign Failure Mode and Effects AnalysisSystem Hazard Analysis
Tech Stack
Tools & technologiesAndroidCloudiOS
About the role
Key responsibilities & impact- Facilitate Agile teams and manage sprint execution
- Coordinate delivery within regulated medical device software environments
- Remove impediments and manage risks and dependencies
- Drive team accountability and delivery excellence
- Ensure alignment with Definition of Ready and Definition of Done
- Coordinate release documentation requirements and support documentation readiness with the Release Manager
- Define and report Key Performance Indicators for release and delivery
- Run Risks, Assumptions, Issues, and Dependencies tracking as a program discipline
- Support continuous improvement
- Participate in internal audits, external audits, and corrective and preventive action activities
Requirements
What you’ll need- Working knowledge of Polarion or an equivalent requirements and traceability tool, plus Smartsheet
- Working knowledge of Design History File content and verification and validation artifacts, beyond general awareness of Design Controls
- Working knowledge of the regulatory standards and guidances that govern medical device software and quality systems
- Working knowledge of medical device risk management artifacts, including Design Failure Mode and Effects Analysis, System Hazard Analysis, and Risk Management Control, with the ability to recognize when they impact a release
- Working knowledge of Design Verification activities and the evidence needed to support release readiness
- Experience defining and reporting on Key Performance Indicators used for release and delivery
- Experience running Risks, Assumptions, Issues, and Dependencies tracking as a program discipline, not just contributing to it
- Experience participating in internal audits, external audits, and corrective and preventive action activities
- Experience on a mobile (iOS or Android) or cloud platform product team in a regulated environment
- Experience partnering with a Release Manager on documentation readiness tied to team deliverables
- Expert in Definition of Done and Definition of Ready at the team level, including facilitating their creation, refinement, and enforcement
- Scrum Master certification (Certified Scrum Master, Professional Scrum Master, or Scaled Agile Framework Scrum Master) is nice to have
Benefits
Comp & perks- Equal Opportunity Employer
- Inclusive workplace committed to diversity and ensuring everyone can thrive