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Strong employer brand plus common Test Engineer title increases applicant density despite regulated-medical-device specialization.
Highly regulated medical-device SOUP, IEC 62304, and SBOM expertise limit cross-industry transferability.
Mandatory 7+ years, regulated-device experience, and IEC 62304/V&V requirements create strict shortlisting filters.
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Lead identification, specification, risk assessment, validation, and lifecycle management of Software of Unknown Provenance (SOUP) for regulated medical devices.
Coordinate cross-functional teams to ensure third-party and open-source software is properly documented, validated, secured, and ready for release.
Develop and maintain SOUP validation strategies, traceability matrices, risk analyses, and support audits and regulatory submissions related to SOUP.
Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related technical field.
Minimum 7 years relevant experience in software engineering, quality, V&V, or product development; at least 3 years with regulated medical device software or highly regulated industry.
Demonstrated knowledge of IEC 62304 and experience managing third-party, open-source, or SOUP software in regulated environments.
Strong experience with software requirements, test methods, validation documentation, risk management, and traceability.
Experienced in operating within medical device software lifecycle processes and regulatory compliance frameworks.
Capable of technical leadership, mentoring engineers, and facilitating cross-functional collaboration for software validation and quality.
Proficient in interpreting software architecture, dependencies, and release documentation to ensure software safety and compliance.