Senior Software Release Manager (MedTech/Regulated Systems)

The role

The Senior Release Manager will manage release and change artifacts for regulated systems. This role involves coordinating cross-platform releases across iOS, Android, and Cloud under a shared Agile Release Train cadence.

What you will do

• Define and report on Key Performance Indicators used for release and delivery
• Run Risks, Assumptions, Issues, and Dependencies tracking as a program discipline
• Participate in internal audits, external audits, and corrective and preventive action activities
• Coordinate cross-platform releases across iOS, Android, and Cloud under a shared Agile Release Train cadence

Required qualifications

• 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
• 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
• 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 s
• 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

About the company

Goods & Services is a product design and engineering company that solves mission-critical challenges for large enterprises in regulated industries. They use a design-led approach with expertise in AI, Data and Hardware Engineering.