Product Security Engineer - Regulatory Compliance (Medical Devices)

Trident Consulting is seeking a “Sr. Product Security Engineer” for one of our clients in “Burlington, MA” — a global leader in pharmaceutical and medical technology.

Position: Sr. Product Security Engineer – Medical Devices

Location: Burlington, MA (Onsite)

Type: Fulltime

Job Summary

Seeking a Senior Product Security Engineer to lead product security across the lifecycle, ensuring compliance with FDA, ISO, NIST, and OWASP standards. Role includes security architecture, secure SDLC, DevSecOps, vulnerability management, and regulatory documentation.

Key Responsibilities

• Define security architecture, threat modeling, and risk mitigation
• Implement Secure SDLC (secure coding, code reviews, OWASP practices)
• Secure CI/CD pipelines, DevSecOps, secrets & supply chain security (SBOM)
• Perform security testing (SAST, DAST, SCA, fuzzing, penetration testing)
• Manage vulnerability assessment, incident response, CVE tracking, patching
• Develop regulatory documentation (FDA, ISO 14971, IEC 81001-5-1)
• Collaborate with Engineering, QA, DevOps, and Compliance teams

Required Skills & Experience

• 7–10 years in Product Security / Application Security / Cybersecurity
• Strong in Security Architecture, Threat Modeling, Vulnerability Management
• Experience with Embedded Systems / IoT Security / Connected Devices
• Expertise in DevSecOps, CI/CD Security, Docker/Kubernetes, Cloud (AWS/Linux)
• Hands-on with SAST, DAST, SCA, Pen Testing tools
• Knowledge of Cryptography (TLS, encryption, key management)
• Familiar with NIST 800-53/30, ISO 27001, ISO 14971, OWASP, CWE, SBOM (SPDX, CycloneDX)
• Experience in regulated industries (Medical Device / Automotive / Aerospace / Defense)

Preferred

• Experience as Product Security Lead / Security SME
• Exposure to FDA cybersecurity guidelines & audits
• Experience with security automation in CI/CD

Education

• Bachelor’s in CS / Engineering / Cybersecurity
• Master’s preferred