Sr. Manager, Medical Device Cyber Security

Tempus AI · Vertical AI · Chicago, IL

This role manages the medical device cybersecurity program, ensuring secure-by-design principles and adherence to FDA guidelines throughout the device lifecycle, bridging enterprise security strategy with product execution.

What you'd actually do

  1. Develop, implement, and continuously mature the Medical Device Cybersecurity roadmap, policies, and Standard Operating Procedures (SOPs), aligning them with the overarching enterprise data security strategy.
  2. Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development.
  3. Ensure device design and lifecycle management align with FDA pre-market and post-market cybersecurity guidelines.
  4. Mentor, and develop the Medical Device Cybersecurity Analyst(s), guiding their daily tactical execution, vulnerability assessments, and professional growth.
  5. Oversee the continuous monitoring, vulnerability scanning, and patching strategies for deployed medical devices.

Skills

Required

  • information security
  • FDA Cybersecurity Guidance (Pre-market and Post-market)
  • ISO 14971
  • ISO 13485
  • threat modeling methodologies (STRIDE, PASTA)
  • secure architecture design
  • program management
  • stakeholder alignment
  • written and verbal communication

Nice to have

  • CISSP
  • HCISPP
  • CISM
  • relevant SANS certifications

What the JD emphasized

  • FDA cybersecurity guidelines
  • secure-by-design principles
  • SSDLC practices