Senior Quality Software Engineer, NPD - IHFM

Role responsibilities

Coordinate software design and verification activities across the IHFM product suite, including digital applications and data platforms. Drive defect triage, quality assessment, and the development of custom test systems to ensure compliance with medical device standards.

Requirements

Requires a Bachelor's degree in Engineering with 4 years of experience, or a Master's with 3 years, or a PhD. Candidates should have expertise in medical device software standards (IEC 62304) and proficiency in Azure DevOps.

Key skills

Software Verification, V&V Planning, IEC 62304, ISO 13485, ISO 14971, Azure DevOps, Agile, Lean Methodologies, System Integration Testing, Root-cause Analysis, Medical Device Regulations, Software Design Control, Cybersecurity Testing, Hardware-Software Integration, Technical Writing, SaMD

Keywords

IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820, Azure DevOps, SaMD, V&V, SDLC, Agile, Lean, .NET Core, Java, Python, GoLang, Rust, Databricks, Scala, Cybersecurity, BLE, Jira, Jama, Codebeamer, Helix ALM, TestRail, ISTQB, CSTE, ASQ, Implantable Heart Failure Management, Medical Device Manufacturing, Signal Processing