Senior Scrum Master - Regulated Medical Device Software

goodsservices; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

goodsservices is seeking a Scrum Master to guide Agile delivery for a team building regulated medical device software. You will facilitate sprints, coordinate delivery, and oversee risks, dependencies, and release readiness.

You will partner with QA and regulatory functions to ensure evidence and Design History File content meet compliance, and you will report progress with KPIs while promoting continuous improvement.

Qualifications

• Experience as a Scrum Master in a mobile or cloud product within a regulated environment.
• Knowledge of medical device software regulations, quality systems, Design Controls, and Design History File content.
• Familiarity with verification and validation evidence, design verification, and risk artifacts (FMEA/HA).
• Experience managing risk, assumption, issue, and dependency tracking as a program practice, and participating in audits and CAPAs.
• Ability to define and report delivery or release KPIs and partner with release management on documentation.
• Strong command of Definition of Ready and Definition of Done, including developing and applying them.
• Working knowledge of Polarion and Smartsheet as requirements/traceability tools.
• Nice to have Scrum Master certifications (CSM/PSM/SAFe SM).

Responsibilities

• Facilitate team planning and delivery, maintaining alignment with readiness and completion criteria.
• Track program risks, assumptions, issues, and dependencies; surface blockers to delivery or release.
• Coordinate with the Release Manager on documentation readiness for team deliverables.
• Monitor delivery and release indicators, and report progress using KPIs.
• Support audit activities and corrective/preventive actions, promoting continuous improvement.
• Assess whether risk-management findings or quality artifacts affect release readiness.

Skills

Scrum Master experience

KPI reporting

Risk/Issue/Dependency tracking

Definition of Ready/Done

Release documentation coordination

Audit participation

Medical device regulatory knowledge

Verification & Validation familiarity

Regulated environment experience

Tools

Polarion

Smartsheet

Job description

goodsservices is seeking a Scrum Master to guide Agile delivery for a team building regulated medical device software. You will facilitate sprints, coordinate delivery, and oversee risks, dependencies, and release readiness.

You will partner with QA and regulatory functions to ensure evidence and Design History File content meet compliance, and you will report progress with KPIs while promoting continuous improvement.