Back
Strong employer brand but niche regulated-medical-device specialty reduces applicant density.
Highly specific medical-device SOUP, IEC 62304, and SBOM expertise limits cross-industry transferability.
Mandatory 7+ years and specific IEC 62304 and regulated-software validation experience enforce strict screening.
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Lead the management of Software of Unknown Provenance (SOUP) through its entire lifecycle for regulated medical device products according to IEC 62304 and regulatory standards.
Develop, maintain, and validate SOUP specifications, risk assessments, and traceability matrices ensuring alignment with software architecture, risk management, and release-readiness documentation.
Collaborate cross-functionally with engineering, quality, regulatory, legal, and cybersecurity teams to ensure compliance, risk mitigation, and readiness for audits and regulatory submissions related to third-party software.
Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related technical field.
Typically 7+ years of relevant experience in software engineering, software quality, systems engineering, V&V, or product development.
Minimum 3 years experience supporting software for regulated medical devices or similarly regulated industries.
Demonstrated knowledge of IEC 62304, risk-based software lifecycle practices, and experience specifying, assessing, validating, or maintaining third-party/open-source/SOUP software.
Experienced in managing software lifecycle compliance within medical device or highly regulated environments, specifically with SOUP and third-party software components.
Detail-oriented professional skilled in documentation control, software risk management, bi-directional traceability between requirements and test evidence, and preparing validation and risk analysis technical documents.
A cross-functional collaborator capable of leading process improvements and supporting audits, with strong communication skills and ability to interpret complex software architecture and release data.