Description
Project Overview
GlobalLogic is partnering with a client, a world leader in the development of in-vitro diagnostics and medical devices. We are seeking an experienced Medical Device Software Systems Engineer to support a critical compliance initiative for existing legacy software. In this role, you will play a pivotal part in remediating the software Design History File (DHF) and bringing legacy systems up to modern regulatory standards.
Position Overview
As a Senior Software Systems / Requirements Engineer, your primary responsibility will be updating software requirements and rebuilding end-to-end traceability for legacy medical device software. You will act as the bridge between existing software development, QA, and systems teams to perform gap analysis, update technical documentation, and ensure that the product strictly adheres to FDA Design Controls and IEC 62304 guidelines.
Requirements
Required Qualifications:
- Experience: 8+ years of experience as a Systems Engineer, Requirements Engineer, or Quality/Compliance Engineer specifically within the Medical Device industry.
- Regulatory Knowledge: Deep, applied understanding of IEC 62304 (Medical device software – Software life cycle processes) and FDA Design Controls (21 CFR Part 820.30).
- Remediation Expertise: Proven track record of working on legacy software remediation, DHF updates, or retrospective documentation projects.
- Traceability & Risk: Strong understanding of how to link risk management (ISO 14971) to software requirements and verification evidence.
- Tooling: Proficiency in modern Requirements Management and ALM tools (e.g., Jama, DOORS, Polarion, Jira/Zephyr/Xray, or similar).
- Soft Skills: Strong analytical mindset, meticulous attention to detail, and excellent communication skills to interview developers and extract system behaviors into formal requirements.
Nice to Have:
- Background in software development (C++, C#, or embedded C) to better understand legacy code architecture and effectively communicate with the development team.
- Experience with in-vitro diagnostic (IVD) devices.
- Familiarity with Agile methodologies applied in a regulated medical environment.
Job responsibilities
DHF Remediation: Lead the assessment and remediation of the software Design History File (DHF) for legacy medical products.
Requirements Management: Update, refine, and author System and Software Requirements Specifications (SRS) to ensure they are unambiguous, testable, and compliant with regulatory standards.
End-to-End Traceability: Rebuild and maintain comprehensive traceability matrices. Establish clear, unbroken linkages between system/software requirements, risk controls, architectural design, and verification/validation (V&V) evidence.
Gap Analysis: Collaborate closely with existing software developers and systems engineers to identify and close gaps in current requirements and documentation.
Risk Control Integration: Ensure that software risk mitigations (derived from ISO 14971 hazard analysis) are properly translated into software requirements and verified accordingly.
Cross-Functional Collaboration: Serve as the subject matter expert on software requirements, guiding the technical teams through the remediation lifecycle.
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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.
