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Tier-1 brand, metro location, and common QA title increase applicant density despite regulated specialization.
Strong regulated-medical-device and SOUP/V&V requirements reduce cross-industry transferability.
Requires 7+ years, regulated-device experience, IEC 62304 knowledge, and specific SOUP/V&V skills.
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Lead the identification, specification, risk assessment, validation, and lifecycle management of Software of Unknown Provenance (SOUP) for regulated medical device products.
Collaborate cross-functionally with software engineering, V&V, risk management, cybersecurity, supplier quality, legal, and regulatory teams to ensure third-party software is secure, validated, documented, and release-ready.
Develop and maintain SOUP specifications, validation reports, traceability matrices, and lifecycle documentation in compliance with IEC 62304 and regulatory standards.
Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related technical field.
7+ years of relevant experience in software engineering, software quality, systems engineering, V&V, or product development.
At least 3 years of experience supporting software for regulated medical devices or another highly regulated industry.
Demonstrated knowledge of IEC 62304, risk-based medical device software lifecycle practices, and managing third-party, open-source, or SOUP software.
Experienced in medical device software lifecycle and compliance with regulatory standards (IEC 62304, ISO 14971, FDA cybersecurity guidance).
Strong hands-on skills in software requirements, risk management, validation, traceability, and managing software bills of materials (SBOMs).
Capable of technical leadership and cross-functional collaboration in regulated environments managing complex SOUP activities.