Product Security Engineer with Medical Device

Trident Consulting Inc

Product Security Engineer with Medical Device

Burlington, MA
Full Time
Paid
  • Responsibilities

    Job Description

    Trident Consulting is seeking a " Product Security Engineer” for one of our client in " Burlington, MA (Hybrid)” A global leader in business and technology services.

    Please find additional details about the role below:

    Job Title: Product Security Engineer

    Location: Burlington, MA (Hybrid)

    Job Type: Full Time

    Salary Range: $118K PA to $146K PA with Benefits

    Relocation assistance available (up to $10,000)

    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).
  • Qualifications

    Additional Information

    All your information will be kept confidential according to EEO guidelines.