Teams at Johnson & Johnson

Leads systems engineering for a safety-critical surgical robotic platform across its product lifecycle. Defines system architecture, requirements, interfaces, risk management, verification strategies, and design controls. Coordinates hardware, software, controls, mechanical, clinical, quality, manufacturing, and V&V teams. Supports regulatory submissions, reliability, design transfer, product launches, nonconformance investigations, CAPA, and post-market activities while applying MBSE and UML methods.

Plan, execute, and document verification and validation activities for robotic medical devices ensuring requirements traceability, regulatory compliance, and product safety. Develop V&V strategies, system test plans, automated and manual test methods, maintain test lab infrastructure, investigate failures, support regulatory submissions, and collaborate across systems, software, hardware, manufacturing, and quality teams to enable product release and launch.

Leads nonclinical safety and toxicology strategy across pharmaceutical discovery and development programs. Oversees safety and pharmacokinetic scientists, evaluates toxicology and safety pharmacology data, prepares regulatory documents, supports clinical trials and registrations, conducts risk assessments and due diligence, collaborates with CMC and cross-functional teams, engages health authorities, and mentors scientists.