Product Security Engineer with Medical Device

Trident Consulting
Burlington, MA

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).


About Trident Consulting

Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.

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