Principal Software Cybersecurity Engineer

Job Description:

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships

POSITION SUMMARY

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.  

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• 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.                                       

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• General Office Environment
• Ability to lift up to 25 lbs.
• May travel up to 10% domestically / 10% internationally

MINIMUM QUALIFICATIONS                                                         

• 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.

PREFERRED QUALIFICATIONS

• 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. 

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ