Associate Engineering Director
Core
Leading the Software Quality & V&V organization to ensure product safety, performance, and regulatory compliance for medical devices.
Role type
Senior Software Engineering Manager (V&V)
Builds
Robust software quality frameworks, automated test pipelines, and regulatory-compliant validation deliverables for global R&D product lines.
Domain
Healthcare technology / Medical Device Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software V&V leadership, multi-tier team management, risk-based testing strategies, CI/CD integration, test automation architecture, regulatory standards mastery (IEC 62304, FDA 21 CFR, ISO 13485), defect lifecycle management, cross-functional stakeholder influence, strategic resource planning.
Preferred skills
Master's degree in CS/Biomedical/Electrical Engineering, CSQE or ISTQB Advanced/Expert certification, Lean Six Sigma Green/Black Belt, Agile/Scrum Master certification.
Technologies
Android, iOS, Java, Groovy, Selenium, Appium, Spock Framework, BDD-Gherkin, AWS, Azure.
Responsibilities
Direct test strategy and automation frameworks, manage V&V project execution across multiple product lines, establish strategic partnerships with global R&D teams, oversee end-to-end V&V deliverables for regulatory submissions, drive test efficiency through continuous automation, make critical decisions on software release readiness.
Seniority
Senior, hands-on IC with management responsibilities
