Director - Product Security

Job Summary Location: Houston, TX (remote possible). The Director of Product Security is a key leadership role responsible for the strategic vision, execution, and oversight of the company's product security program. This executive will lead a dedicated team to manage the cybersecurity posture of our medical device portfolio throughout its entire lifecycle, from design and development through post‑market surveillance. Key Responsibilities Strategic Leadership & Program Management: Define and execute a comprehensive product security strategy that aligns with business priorities, FDA/MDR/524B expectations, and Quality Management System (QMS) requirements. Build, lead, and mentor a high‑performing team of product security professionals, fostering their technical and leadership skills. Manage and allocate human and financial resources to achieve strategic objectives. Secure Product Development Lifecycle (SDLC): Drive a "shift‑left" security strategy, integrating security controls and best practices into all stages of the product lifecycle. Oversee a rigorous threat modelling program and lead cybersecurity risk assessments for all new and existing products. Champion DevSecOps principles and automate security controls and testing within CI/CD pipelines. Provide architectural guidance on secure design, including the implementation of secure boot, firmware signing, and encryption. Regulatory Compliance & Governance: Ensure all required cybersecurity documentation, including risk assessments and SBOMs, is prepared and submitted for pre‑market applications (510(k), PMA). Manage the generation and maintenance of SBOMs and VEX documents. Act as the senior product security subject‑matter expert during FDA and other international regulatory inspections. Post‑Market Surveillance & Incident Response: Oversee the post‑market surveillance program to continuously monitor field devices for emerging threats and vulnerabilities. Lead and manage the security incident response process, including coordinated vulnerability disclosure, containment, root‑cause analysis, and remediation. Develop and execute plans for communicating security updates and patches to customers and stakeholders. Cross‑Functional Collaboration & Stakeholder Engagement: Partner with R&D, Engineering, Quality, Regulatory Affairs, and Legal teams to embed security practices and ensure a comprehensive approach to product safety. Serve as the primary security consultant, articulating technical challenges and mitigation plans to senior management and external stakeholders in a clear, non‑technical manner. Engage with customers, hospital IT/IS staff, and industry partners to translate technical requirements into business and clinical impact and build trust in the company’s products. Oversee external communications regarding program and product vulnerabilities; develop and execute strategies for external presence and participation in industry groups, conferences, and thought leadership activities. Required Skills & Qualifications Education: Bachelor’s degree in Computer Science, Cybersecurity, or a related engineering discipline. 15+ years of technical experience in the medical device industry. Experience: Minimum 10 years of progressive experience in cybersecurity, with at least 5 years in a leadership or director‑level role; at least 3 years integrating security into embedded systems or connected medical devices in a regulated product development environment. Technical Knowledge: Deep expertise in secure SDLC, threat modelling, vulnerability management, embedded systems security, IoT security, and cloud architectures. Certifications: Industry‑recognized certifications such as CISSP, CISM, or CSSLP are highly valued. Regulatory Acumen: Proven experience navigating cybersecurity requirements for FDA 510(k) and PMA submissions. Soft Skills: Exceptional leadership, communication, and problem‑solving skills with a proven ability to drive clarity and consensus across broad organizations. Benefits Pay Transparency: $185,000 – $225,000 + discretionary annual bonus, plus potential variation by location. Health benefits – Medical, Dental, Vision. Personal and vacation time. Retirement & Savings Plan (401K). Employee Stock Purchase Plan. Training & Education Assistance. Bonus Referral Program. Service Awards. Employee Recognition Program. Flexible Work Schedules. #J-18808-Ljbffr