Über diese Senior Software Release Manager (MedTech/Regulated Systems) Stelle bei Goods & Services
About Goods & Services
Goods & Services is a product design and engineering company.
We solve mission-critical challenges for some of the world’s largest enterprises, with deep expertise in highly regulated industries—including life sciences and financial services. Our design-led approach allows us to apply cutting-edge capabilities in AI, Data and Hardware Engineering to companies of any size.
Headquartered in the United States, we operate regional development centers in Mexico and the United Kingdom. This global footprint—anchored by our nearshore model—enables us to deliver at scale with the speed, efficiency, and cultural alignment our clients expect.
At Goods and Services, we value diversity and are committed to creating an inclusive workplace where everyone can thrive. We are proud to be an Equal Opportunity Employer and welcome qualified applicants from all backgrounds.
About the job
Goods & Services is looking for a Senior Release Manager with expertise in requirements traceability, design controls, verification and validation, risk management, and regulated quality systems
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.
- 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.
