Senior Software Release Manager (MedTech/Regulated Systems)

Goods & Services is looking for a Senior Release Manager who will serve as the operational bridge between Release Train Engineers (RTEs), Enterprise Program Managers (EPMs), and also work with Systems Engineering, DevOps, Quality, Regulatory, and Commercial teams to ensure mobile software releases are planned, documented, approved, deployed, and monitored successfully. This role owns end-to-end release readiness, documentation coordination, deployment planning, and launch execution activities for mobile software products. The individual ensures all release deliverables are completed on time, dependencies are managed, approvals are obtained, deployment plans are executable, and stakeholders remain informed throughout the release lifecycle. The role does not replace but complements the RTE or EPM by providing dedicated focus on release execution, documentation control, deployment readiness, and hyper care. This supports increased release velocity while maintaining compliance within a regulated medical device environment.

What you’ll do:

Owns deployment planning across Internal releases, Limited Market Releases, Feature Rollouts, International Deployments, Sustaining Patches, and Hotfixes

Coordinates deployment execution with DevOps and IT, including staged rollout strategies, rollback plans, deployment targeting, pilot groups, and production monitoring

Leads release and deployment readiness reviews and facilitates cross-functional go/no-go decisions

Maintains documentation dependency maps and critical path analysis to protect testing, regulatory submission, and deployment timelines

Standardizes release management practices across mobile teams, including reusable templates for deployment plans, readiness reviews, risk tracking, and release reporting

Drives continuous improvement and supports scaling of release processes across multiple concurrent product releases.

What you’ll need:

Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, Information Systems, or a related field

5+ years of experience in software release management, program management, systems engineering, PMO, or technical operations

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.

Hands-on experience with Arena or an equivalent Product Lifecycle Management / electronic Quality Management System.

Expert in the release and change artifact set used by the program: Engineering Change Order, Document Change Order, Design History File, Design Document, Product Change Order, release notes, and the specific Product Design and Development Plan, Design Change Impact Assessment, Product Engineering Integration Test, and Information Technology Change Request documents.

Working knowledge of Limited Market Release and Full Market Release phasing and the readiness criteria for each.

Working knowledge of adjacent medical device records and planning artifacts that interact with release and change activities, including Device Master Record, Bill of Materials, and Change Development Plan.

Experience coordinating cross-platform releases across iOS, Android, and Cloud under a shared Agile Release Train cadence.

Preferred:

PMP and/or Scaled Agile Framework certification

Experience with app store deployments and over-the-air (OTA) update strategies