Principal Software Cybersecurity Engineer

TransMedics, Inc.Andover, MA

About The Position

We are currently seeking a talented and driven Principal Software Cybersecurity Engineer, to join our team. The Principal Cybersecurity Engineer – Software, will have the opportunity to contribute to the life cycle of secure embedded and digital software applications that preserve donated hearts, lungs, livers, and other organs on the OCS.

Requirements

  • BS/MS in Computer Science, Computer Engineering, or equivalent combination of education and experience.
  • 10+ years of related experience in real-time embedded software, digital clinical software, medical device development, or product cybersecurity.

Nice To Haves

  • Experience in implementing security controls and features in firmware and embedded software, such as secure boot, cryptographic services, and secure data storage.
  • Experience in implementing protections for sensitive data stored on or transmitted by embedded devices.
  • Experience in implementing digital signatures to verify the authenticity and integrity of data.
  • Experience in applying secure hashing and generating and managing cryptographic keys.
  • Experience in employing secure communication protocols like TLS/SSL.
  • Experience in medical device security risk assessment, evaluation, and control.
  • Experience in preparing and maintaining SBOM
  • Familiarity with OWASP MASVS and mobile/web application security best practices
  • Familiarity with SAST/SCA tools such as SonarQube (preferred)
  • AWS Certified Security - Specialty certificate or experience with AWS security-related services such as GuardDuty, IAM, Security Hub, and WAF
  • Knowledge of relevant cybersecurity regulations and guidelines (FDA pre-market and post-market guidance, section 2.4b CFR, IEC 81001-5-1, IEC 62443-4-1, JSP 2.0).
  • Knowledge of cybersecurity relevant methods and tools (threat modeling, STRIDE, static/dynamic code analysis, system hardening, penetration testing, etc.).
  • Understanding of post-market surveillance, vulnerability disclosure, CVEs, and incident response in regulated environments.
  • Medical device software development experience with compliance to IEC-62304, IEC-82304, and FDA guidelines is a plus.
  • Knowledge of regulatory and industry standards (e.g., NIST CSF, ISO 27001, IMDRF, EU MDR).
  • Must be team-oriented with outstanding interpersonal and communication skills (written and verbal).
  • Must be detail-oriented and highly organized.

Responsibilities

  • Work with relevant stakeholders to determine customer needs for secure embedded and digital software applications
  • Elicitate cybersecurity software requirements to support customer needs
  • Perform end-to-end system security risk analysis activities
  • Perform threat modeling, vulnerability assessments, pen tests, and static/dynamic analysis (SAST/DAST)
  • Ensure regulatory compliance with FDA pre-market/post-market guidelines, NIST SP 800-series, IEC 62304, and ISO 14971
  • Implement cryptographic controls, secure boot, authentication, and hardened operating systems
  • Create software requirement specs, risk assessments, and secure architecture designs
  • Manage Software Bill of Materials (SBOM) to analyze third-party component risks
  • Support patching and remediation of security vulnerabilities on connected devices
  • Participate in cybersecurity assessment and ensure a secure architecture and design
  • Develop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304
  • Support quality audits and the development of FDA submissions
  • Perform other TransMedics tasks and duties as assigned/required.

Benefits

  • Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
  • Dental
  • Vision
  • Healthcare Flexible Spending Account
  • Dependent Care Flexible Spending Account
  • Short Term Disability
  • Long Term Disability
  • 401K Plan
  • Pet insurance
  • Employee Stock Purchase Plan
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