Sr. Product Security Engineer II bei Glaukos Corporation

Sr. Product Security Engineer

What You’ll Do: 

The Senior Product Security Engineer, based in Burlington Massachusetts, is a critical, high-level engineering position tasked to leading security efforts across the product lifecycle, ensuring products meet regulatory expectations and industry best practices for cybersecurity. This role provides both hands-on technical expertise and cross-functional leadership, with influence over product strategy, development processes, and post-market security posture. 

Security Architecture & Requirements 

• Define security requirements and risk mitigations for new products and features. 
• Translate regulatory and industry security standards (e.g., FDA, ISO 27001, NIST, OWASP) into actionable product requirements. 
• Develop and maintain security architecture diagrams and models for software and integrated systems. 

Development Lifecycle Security 

• Embed secure development practices (threat modeling, secure coding, code review standards) into the software development lifecycle. 
• Define and support secure CI/CD practices, including secrets management, dependency management, and supply-chain security. 
• Partner with DevOps/IT to secure cloud infrastructure, build pipelines, and deployment environments. 

Testing & Validation 

• Assist the testing team with security testing efforts for new and on-market products, including penetration testing, fuzzing, and static/dynamic code analysis. 
• Update and maintain vulnerability management processes, including SBOM creation and maintenance. 
• Collaborate with QA to integrate automated security testing into regression and release pipelines.
• Documentation & Compliance 
• Generate and maintain pre-market security documentation to support regulatory submissions (e.g., security risk assessments, security architecture views, threat models, FDA cybersecurity guidance compliance). 
• Maintain records of vulnerability assessments, mitigations, and patch processes. 
• Support audit and inspection readiness with thorough, traceable documentation

Vulnerability & Incident Management 

• Manage product vulnerability assessment and mitigation activities, both pre-market and post-market. 
• Coordinate cross-functional response to newly discovered vulnerabilities, including communication, remediation, and regulatory reporting. 
• Track and monitor vulnerability disclosures from third-party libraries and components. 

Cross-Functional Leadership 

• Act as the security subject matter expert across product teams. 
• Provide training and mentoring to engineers on secure design and coding practices. 
• Partner with compliance, regulatory, and quality teams to align product security strategy with organizational goals

How You’ll Get There: 

• 7–10 years total professional experience in software engineering, cybersecurity, or related technical fields. 
• 3–5 years focused on product or embedded system security, ideally within regulated or safety-critical industries (medical device, aerospace, automotive, or defense). 
• Demonstrated experience with: 
• Designing or assessing security architectures for embedded or connected systems. 
• Implementing secure development lifecycle (SDL) practices within engineering teams. 
• Leading or participating in vulnerability management and coordinated disclosure processes. 
• Generating pre-market cybersecurity documentation or equivalent regulatory submissions (e.g., FDA, ISO 14971, IEC 81001-5-1). 
• Collaborating cross-functionally (engineering, QA, regulatory, IT) to implement and sustain security programs.

Preferred 

• Prior experience as a product security lead or security point of contact for a commercial medical or industrial product. 
• Experience integrating security testing automation into CI/CD environments. 
• Experience supporting external audits, penetration tests, or third-party security assessments. 

Core Product Security Knowledge 

• Secure system and software design principles (least privilege, defense in depth, threat modeling, zero trust). 
• Risk management frameworks: NIST 800-53, NIST 800-30, ISO 27001, ISO 14971, and IEC 81001-5-1. 
• Cryptography fundamentals (key management, TLS, symmetric/asymmetric encryption, hashing). 
• Authentication and authorization mechanisms, identity management, and secure session handling. 
• Secure coding standards (e.g., CERT C/C++, OWASP, MISRA, CWE/SANS Top 25). 
• Supply chain security concepts and SBOM management (SPDX, CycloneDX). 

DevOps & Infrastructure Knowledge 

• CI/CD security practices, secrets management, container security (Docker, Podman), and artifact signing. 
• Common security testing tools: SAST, DAST, SCA, fuzzers, and pen-testing frameworks. 
• Familiarity with cloud infrastructure (AWS, or on-prem Linux environments). 
• Incident response and vulnerability disclosure processes. 

Regulatory & Documentation Knowledge 

• FDA cybersecurity premarket and postmarket guidance. 
• Secure update/patch management strategies (aligned with FDA “updateability & patchability” expectations). 
• Audit-ready documentation practices and traceability to design controls. 

Minimum 

• Bachelor’s degree in Computer Science, Electrical/Computer Engineering, Cybersecurity, or a related field. 

Preferred 

• Master’s degree in Cybersecurity, Software Engineering, or Systems Engineering (ideal for regulated product security leadership). 

Company