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.

What we offer

Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.

Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.

DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.

Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.

Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.

Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.

About GlobalLogic

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.