Senior Quality Software Engineer, NPD - IHFM
Core
Lead software quality engineering, verification, and validation for Implantable Heart Failure Management (IHFM) medical devices, ensuring compliance with FDA and IEC standards while driving test strategy and defect resolution.
Role type
Senior Quality Software Engineer (Medical Device)
Builds
Implantable Heart Failure Management (IHFM) product suite including digital applications, microservices, and data platforms
Domain
Medical Device / Implantable Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software verification and validation (V&V), Test strategy design, Defect triage and root cause analysis, Regulatory compliance (FDA/IEC), Agile/Lean methodologies, System integration testing, Technical leadership, Cross-functional collaboration
Preferred skills
IEC 62304 Medical Device Software experience, Hardware-software integration testing, Software and hardware system testing, Technical writing, Medical device regulations knowledge, UI experience, Azure DevOps proficiency, Design control processes, Global regulatory frameworks, Cybersecurity testing, ALM tools, Cardiac technology background, Quality certifications (ISTQB/CSTE/ASQ)
Technologies
.NET Core, Java, Python, GoLang, Rust, Databricks, Python/Scala, Azure DevOps, Jira, Jama, Codebeamer, Helix ALM, TestRail
Responsibilities
Coordinate software design activities across UI, signal processing, DevOps, and security; Develop SW verification strategy and V&V plans; Drive defect triage and root-cause analysis; Support end-to-end system integration testing; Influence product design with quality perspectives; Champion Agile and Lean methodologies; Ensure manufacturability and support regulatory submissions.
Seniority
Senior, hands-on IC with technical leadership