Vipin Saxena

Responsibilities:

Analysis of cybersecurity and regulatory requirements for robotic-assisted surgery systems.

Development of threat models (STRIDE) and cybersecurity risk assessments by FDA premarket guidance.

• Created security documentation for FDA 510(k) submission, including SBOM and Cybersecurity Test Summary.

• Designed and reviewed penetration testing and vulnerability assessment plans for robotic subsystems.

• Implemented secure design controls and access control policies.

• Collaborated with R&D and Quality teams for security alignment with safety risk management.

Post-market vulnerability management and incident response planning.

Responsibilities :

• Led comprehensive security assessments, identifying vulnerabilities and implementing solutions that enhanced overall risk management practices.
• Developed and executed security policies and frameworks, ensuring compliance with industry regulations and improving organizational security posture.
• Collaborated with cross-functional teams to design and implement security architectures, resulting in streamlined processes and reduced incident response times.
• Mentored junior consultants on best practices in cybersecurity, fostering professional growth and enhancing team capabilities.
• Performing penetration testing.

• Conducted threat modeling and risk assessments for software and hardware modules.
• Performed vulnerability triage and coordinated remediation for findings from penetration testing, SAST, and SCA tools.
• Developed security deliverables for FDA 510(k) submissions, including SBOM, Risk Assessment, and Maintenance Plans.
• Defined post-market cybersecurity processes, including Coordinated Vulnerability Disclosure (CVD).
• Conducted Data Protection Impact Assessments (DPIA) to ensure compliance with data privacy regulations.
• Managed Third-Party Risk Management (TPRM) activities, including supplier security assessments and remediation tracking.
• Integrated SDL practices and conducted supplier risk evaluations.

• Developed and executed comprehensive test plans to ensure software functionality met quality standards and user requirements.
• Collaborated with cross-functional teams to identify and troubleshoot defects, improving system reliability and user experience.
• Automated testing processes using industry-standard tools, resulting in enhanced efficiency and reduced testing timeframes.
• Led the implementation of Agile methodologies, fostering a culture of continuous improvement and timely project delivery.
• Conducted performance and regression testing to validate software updates, ensuring seamless integration with existing systems.