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Director - Product Security

LivaNova

LivaNova

Implants

Minneapolis, MN - USA

Responsable de département

Hybride

Experteer Overview

As Director of Product Security, you will lead the global product security program for our medical device portfolio, guiding strategy, execution, and governance throughout the lifecycle. You will build and mentor a security-focused team, ensure regulatory alignment (FDA/MDR/524B) and QMS, and drive risk-based decisions that protect patients and preserve market access. This role blends hands-on technical leadership with cross-functional influence and external stakeholder engagement. You will shape secure development, incident response, and post-market surveillance at scale, delivering measurable impact for patient safety and business growth.

Rémunérations / Avantages

  • Health benefits – Medical, Dental, Vision
  • Retirement & Savings Plan (401K)
  • Employee Stock Purchase Plan
  • Flexible Work Schedules
  • Training & Education Assistance
  • Bonus Referral Program

Responsabilités

  • Define and execute a comprehensive product security strategy aligned with priorities and regulatory expectations
  • Build, lead, and develop a high-performing product security team
  • Manage resources (people and budget) to achieve strategic objectives
  • Drive shift-left security across the product lifecycle and integrate security into SDLC
  • Conduct threat modeling and cybersecurity risk assessments for new and existing products
  • Champion DevSecOps and automate security controls/testing in CI/CD pipelines
  • Provide architectural guidance on secure design and controls (secure boot, firmware signing, encryption)
  • Ensure cybersecurity documentation for premarket submissions (510(k), PMA) and maintain SBOMs/VEX
  • Represent the company in FDA and international regulatory inspections
  • Oversee post-market surveillance and incident response, including vulnerability disclosure and remediation
  • Coordinate with R&D, Engineering, Quality, Regulatory Affairs, and Legal to embed security practices
  • Communicate security concepts to senior management and external stakeholders clearly
  • Engage with customers and partners to translate technical requirements into business impact
  • Lead external communications on vulnerabilities and contribute to industry thought leadership

Principales exigences

  • Bachelor in Computer Science
  • 15+ years of technical experience in the medical device industry
  • 10+ years in cybersecurity with 5+ years in leadership
  • 3+ years integrating security into embedded systems or connected medical devices in a regulated environment
  • Deep expertise in secure SDLC, threat modeling, and vulnerability management
  • Strong understanding of embedded systems, IoT security, and cloud architectures
  • CISSP/CISM/CSSLP or similar certifications valued
  • Experience navigating FDA 510(k) and PMA submissions
  • Exceptional leadership, communication, and problem-solving skills

Description du poste

As Director of Product Security, you will lead the global product security program for our medical device portfolio, guiding strategy, execu…
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