Senior Software Design Assurance / DHF Remediation Engineer (Medical Device) IRC304546

Description

Project Overview

GlobalLogic is partnering with a US Med Device manufacturer to execute a comprehensive Design History File (DHF) remediation project for legacy medical device software. We are building a specialized compliance and documentation team to ensure that existing life-saving diagnostics software strictly adheres to FDA and international regulatory standards.

Position Overview

We are seeking a highly experienced Software Design Assurance / Quality Engineer to drive overall DHF completeness and compliance. In this role, you will be the definitive authority on software design quality, acting as the primary gatekeeper for DHF documentation. You will actively manage, assess, and remediate the complete software lifecycle documentation suite, ensuring that all planning, verification, validation, and release records meet IEC 62304, ISO 13485, and FDA 21 CFR Part 820.30 requirements.

Requirements

Experience: 8+ years of experience in Software Design Assurance, Quality Engineering, or Regulatory Affairs within the Medical Device industry.

Regulatory Mastery: Deep working knowledge of FDA Design Controls (21 CFR Part 820.30), IEC 62304 (Medical device software lifecycle), and ISO 13485 (Quality management systems).

Remediation Expertise: Demonstrated hands-on experience executing DHF remediation programs, retrospective gap analyses, and legacy compliance updates.

V&V Experience: Strong background in reviewing and approving software verification and validation protocols, test reports, and anomaly logs.

Analytical Rigor: Exceptional attention to detail with the ability to cross-reference multiple compliance documents for consistency and completeness.

Communication: Strong interpersonal skills to collaborate with software architects, requirements engineers, and technical SMEs in a heavily regulated environment.

Nice to Have

– ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) designation.

– Experience in the in-vitro diagnostic (IVD) medical device sector.

– Familiarity with risk management principles under ISO 14971.

Job responsibilities

DHF Completeness & Assessment: Conduct comprehensive gap analyses of the existing Software Design History File (DHF) against internal Nova Biomedical Quality Management System (QMS) procedures and applicable regulatory requirements.

Lifecycle Documentation Support: Draft, review, and remediate foundational software lifecycle documents, including the Software Development Plan (SDP), Configuration Management Plan, and Software Release documentation.

V&V Oversight: Support and review Verification & Validation (V&V) planning, test protocols, and summary documentation to ensure rigorous test coverage and traceability.

Design Review Facilitation: Ensure formal design review records are thoroughly documented, action items are closed, and historical design phases are properly justified.

Anomaly Management: Oversee anomaly and defect documentation, ensuring that legacy software bugs are properly logged, risk-assessed, and traced to mitigation strategies.

Audit Readiness: Organize and package the remediated DHF deliverables to ensure the software history is fully transparent, logically structured, and ready for regulatory audits.

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.