SW Tool Validation Lead
Core
Lead end-to-end software tool validation and computer system validation (CSV) for medical device systems, ensuring they are fit for intended use through a risk-based assurance approach.
Role type
Senior IC validation lead (medical device software)
Builds
Validated software tools and integrated systems for preventative healthcare
Domain
Medical device / Regulated software
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Computer system validation (CSV), risk-based assurance, GAMP 5 Second Edition, FDA Computer Software Assurance, ISO/TR 80002-2, AI/ML system validation in regulated contexts, team leadership, audit defense, EU MDR, ISO 13485, FDA 21 CFR Part 820/11, EU GMP Annex 11
Preferred skills
Azure DevOps, data integrity (ALCOA+), cloud-native/SaaS platforms, Notified Body or FDA inspection experience, Swedish or German language skills
Technologies
Azure DevOps, GAMP 5, FDA CSAG, ISO/TR 80002-2
Responsibilities
Set direction and coach the CSV team; design and run assurance activities including testing and risk mapping; maintain validated state during changes and integrations; own assurance of AI-enabled tools; manage findings and issues; represent the function in audits and Notified Body assessments
Seniority
Senior, hands-on IC
