Post-Market Software Reliability Engineering Manager - CRM
Core
Leading post-market quality processes, software reliability engineering, and field action/recall support for cardiac and vascular medical devices to ensure product safety and regulatory compliance.
Role type
Senior Manager, Post-Market Software Reliability Engineering
Builds
Embedded software quality and reliability for cardiac rhythm management devices
Domain
Medical Devices / Cardiac Rhythm Management / Regulated Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Post-market surveillance, root cause analysis, CAPA management, team leadership, regulatory compliance (ISO 13485, IEC 62304), risk assessment, quality metrics management
Preferred skills
Certified Reliability Engineer (CRE), Certified Software Quality Engineer (CSQE), Design for Reliability (DfR), FMEA/FTA, DevOps, Agile, Six Sigma
Technologies
Cloud-based services, mobile applications, automated testing tools, project management software
Responsibilities
Lead post-market quality strategy and execution; oversee root cause investigations and corrective actions; manage post-market surveillance programs; lead and develop a team of software reliability engineers; ensure compliance with global quality and regulatory standards
Seniority
Manager, hands-on leadership