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Tier-1 employer, generic 'Test Engineer' title, and Hyderabad metro increase applicant competition.
Role requires regulated-medical-device SOUP, IEC 62304, SBOM and V&V expertise, limiting transferability across industries.
Explicit 7+ years, 3+ years regulated-device experience, IEC 62304, and mandated validation/documentation create strict filters.
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Lead identification, specification, risk assessment, validation, and lifecycle management of Software of Unknown Provenance (SOUP) for regulated medical devices.
Collaborate cross-functionally to ensure third-party and open-source software is properly selected, validated, documented, traceable, secure, and release-ready.
Establish and maintain inventories, develop SOUP specifications, support risk management and validation, and lead audits and regulatory submissions related to SOUP.
Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related technical field.
Typically 7+ years in software engineering, software quality, systems engineering, V&V, or product development.
Minimum 3 years supporting software for regulated medical devices or another highly regulated industry.
Demonstrated knowledge of IEC 62304 and experience with third-party, open-source, or SOUP software validation and lifecycle management.
Experienced in regulated medical device software lifecycle management with strong expertise in IEC 62304 compliance and risk-based approaches.
Proficient in software requirements, test methods, traceability, risk management, and documentation control related to SOUP.
Skilled at cross-functional leadership, technical review, mentoring, and managing complex software validation and audit processes.