Senior Enterpise Software Test Engineer
Core
Lead identification, specification, risk assessment, validation, and lifecycle management of Software of Unknown Provenance (SOUP) for regulated medical devices.
Role type
Senior Software Quality Engineer (Medical Device SOUP)
Builds
Regulated medical device software products ensuring third-party and open-source software is validated and release-ready
Domain
Healthcare / Medical Device Software / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IEC 62304 compliance, risk-based software lifecycle management, SBOM management, software requirements traceability, validation strategy development, cross-functional technical leadership, controlled documentation, vulnerability assessment
Preferred skills
ISO 14971, FDA cybersecurity guidance, embedded/cloud-connected medical device software, open-source license evaluation, audit response
Technologies
Jira, requirements-management tools, document-control systems, source control, dependency scanning, SBOM platforms
Responsibilities
Lead SOUP activities throughout the product lifecycle; Establish and maintain a complete inventory of third-party software components; Develop and maintain SOUP specifications with acceptance criteria; Assess existing SOUP records and remediate documentation gaps; Support software safety classification using a risk-based approach; Integrate SOUP failure modes into product software risk analyses; Develop validation strategies and map SOUP requirements to verification evidence; Review test protocols and reports for adequacy; Prepare and maintain SOUP validation reports and traceability matrices; Coordinate commercial software assessments and open-source license reviews; Support design reviews and release-readiness reviews; Establish sustainable workflows for periodic SOUP review and post-market monitoring; Provide technical leadership and mentor engineers; Support internal and external audits related to SOUP controls.
Seniority
Senior, hands-on IC with mentorship responsibilities