Senior Cybersecurity Engineer

Summary

Join Q Bio, a healthcare transformation company using AI, Physics, and Biology to automate physical exams, as a Senior Cybersecurity Engineer. You will play a key role in designing, building, automating, and maintaining the secure deployment and monitoring of our cutting-edge products. This position focuses on embedding security throughout the product lifecycle, ensuring compliance with FDA regulations and other relevant standards. You will lead threat modeling, risk analysis, and vulnerability management, while also developing and maintaining incident response plans. The role also involves managing corporate security, compliance frameworks (SOC 2, HIPAA), and third-party risk. This is a senior position requiring significant experience in cybersecurity and a strong understanding of medical device regulations.

Requirements

• 5+ years of experience in cybersecurity, with at least 3-5 years in a hands-on, senior or lead role
• Proven experience in a regulated industry, with a strong preference for MedTech (medical devices), HealthTech, or Life Sciences
• FDA Expertise: Demonstrated, hands-on experience with FDA cybersecurity guidance for medical devices, contributing to the cybersecurity sections of regulatory submissions (e.g., 510(k), PMA), and acting as a subject matter expert in direct interactions with regulatory bodies (e.g., responding to submission questions, participating in audits)
• Compliance Expertise: Direct experience leading or playing a primary role in achieving and maintaining SOC 2 and/or HIPAA compliance
• Product Security: Strong experience with application security, secure SDLC practices, threat modeling (e.g., STRIDE), and vulnerability management for software products
• Cloud Security: Deep knowledge of securing cloud environments and services (AWS, GCP, or Azure)
• Technical Skills: Proficiency with security assessment tools, IAM systems, endpoint protection, and network security concepts
• Bachelor's degree in Computer Science, Information Security, or a related field

Responsibilities

• Secure Software Development Lifecycle (SDLC): Integrate security best practices and tools into every phase of the product development lifecycle, from design and requirements to coding, testing, and deployment
• Threat Modeling & Risk Analysis: Lead and perform threat modeling and security risk analysis (per ISO 14971) for new and existing medical device software
• FDA & Regulatory Compliance: Author, review, and own all cybersecurity-related documentation for regulatory submissions (e.g., FDA 510(k) pre-market and post-market management plans). Ensure our products and processes align with the latest FDA guidance, IEC 62304, and other relevant medical device security standards
• Regulatory Interface: Serve as the primary cybersecurity subject matter expert (SME) for regulatory interactions, including responding to questions during FDA submissions and representing the company's cybersecurity posture during audits
• Security Requirements Definition: Partner with Product Management, Engineering, and Quality teams to define and document security requirements, controls, and architecture for our medical device platforms
• Vulnerability Management & Penetration Testing: Manage and coordinate third-party penetration testing and internal vulnerability assessments of our products. Develop and oversee the remediation action plan
• Incident Response: Develop, implement, and maintain an incident response plan for product-related security events, including vulnerability disclosure policies
• Continuous Security Assessment & Strategy: Continuously assess the company's security posture against evolving business needs and emerging threats. Identify relevant security standards (e.g., SOC 2, HIPAA, NIST CSF), perform regular gap analyses, and own the strategic roadmap for assessment, implementation, and improvement
• Compliance Frameworks (SOC 2 / HIPAA): Lead the initiative to achieve and maintain SOC 2 certification for our platform and business operations. Develop and manage the security controls and policies required for SOC 2 and HIPAA Security Rule compliance
• Corporate Security Governance: Develop, implement, and enforce company-wide information security policies, procedures, and standards
• IT & Cloud Security: Conduct security architecture reviews and risk assessments of our corporate IT and cloud infrastructure (AWS/GCP/Azure). Implement and manage security controls to protect corporate data and systems
• Vendor & Third-Party Risk Management: Establish and manage a program to assess and monitor the security posture of third-party vendors and partners
• Identity & Access Management (IAM): Oversee and improve the company's IAM policies and solutions to ensure the principle of least privilege is maintained

Preferred Qualifications

Relevant professional certifications are highly desirable (e.g., CISSP, CISM, HCISPP, CSSLP)