Senior Software Architect (Medical Device Documentation) IRC304290

Description

Project Overview

GlobalLogic is partnering with a client, a global leader in in-vitro diagnostics and medical devices, to execute a critical compliance and software remediation initiative. We are building a dedicated team to retrospectively update the Design History File (DHF) for legacy medical device software, ensuring full compliance with modern FDA regulations and IEC 62304 standards.

Position Overview

We are looking for a Senior Software Architect or highly experienced Lead Software Engineer with a strong background in technical documentation and reverse-engineering. In this role, you will lead the remediation of the Software Architecture and Detailed Design documentation for an existing medical device. You will act autonomously to reconstruct system blueprints—mapping out components, interfaces, and data flows—while utilizing the existing development team primarily as Subject Matter Experts (SMEs) and reviewers.

Requirements

Experience: 10+ years of experience in software engineering, with at least 3+ years acting as a Software Architect, Lead Developer, or Systems Designer.

Code Literacy: Exceptional ability to read, navigate, and comprehend large, complex, and legacy codebases (experience with C++, C#, Java, or Embedded C is highly preferred).

Modeling & Diagramming: High proficiency in UML, SysML, or similar modeling languages to visually represent architectures, sequence diagrams, and component relationships using tools like Enterprise Architect, MagicDraw, or Visio.

Technical Writing: Excellent technical writing skills with the ability to translate complex software behaviors into clear, formal, and audit-ready documentation.

Autonomy: Strong ability to work independently, driving the documentation process proactively rather than relying on others to supply the architecture.

Job responsibilities

Architecture Reconstruction: Reverse-engineer and deeply analyze existing legacy software to thoroughly understand its structure, behaviors, and design paradigms.

Documentation Leadership: Lead the creation and remediation of formal Software Architecture and Software Detailed Design documents in alignment with IEC 62304 requirements.

System Mapping: Accurately document software components, internal and external interfaces, complex data flows, state machines, and system dependencies.

Design Rationale: Identify, capture, and document key historical design decisions and their rationales.

SME Collaboration: Conduct targeted technical interviews and code review sessions with the current development team to extract necessary architectural knowledge without disrupting their daily operations.

Regulatory Alignment: Ensure that all architectural documentation supports risk management mitigations (ISO 14971) and integrates seamlessly with the broader DHF remediation effort.

Nice to Have:

• Familiarity with in-vitro diagnostic (IVD) systems or embedded hardware-software interfaces.