Principal Cybersecurity Assurance Engineer; Remote

Principal Cybersecurity Assurance Engineer

Job Description:

• Leading cybersecurity assurance activities throughout the product life cycle, including creating cybersecurity risk management plans, threat modeling, performing vulnerability assessments, defining security architecture, creating SBOMs, managing vulnerabilities and cybersecurity risks, planning and monitoring security testing, including penetration testing, writing cybersecurity risk management reports, and ensuring traceability between security controls, security requirements, and security testing.
• Ensuring compliance with applicable regulatory requirements and industry standards, while immediately elevating to management any major problem that could affect patient safety, cybersecurity, customer usability, or system adherence to process requirements.
• Acting as a cybersecurity champion within product development teams by analyzing system designs for vulnerabilities, determining cyber risk profiles, estimating security risks, defining security controls, interacting with hardware and software engineers, Design Assurance, Quality, and Regulatory teams to ensure compliance with cybersecurity regulations and ATO readiness, and collaborating with other security teams to monitor and respond to cyber signals.
• Supporting continuous process improvement, external audits and submissions, the CAPA process, supplier audit processes, and other quality‑related processes regarding cybersecurity risk management and software assurance.
• Supervising, mentoring, guiding, and coaching other cybersecurity assurance engineers.
• Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

• Bachelor’s degree or higher (completed and verified prior to start) AND eight (8) years of cybersecurity and/or cybersecurity risk management experience supporting medical devices.
• Experience working with embedded systems, Internet of Things (IoT) devices, Bluetooth, Wi‑Fi, and/or cellular technologies.
• Experience applying premarket and postmarket medical device regulations and standards such as FDA requirements, EU regulations, IEC 81001‑5‑1, ISO 13485, ISO 14971, IEC 62304, or similar standards.
• Experience leading and documenting threat modeling and vulnerability assessments for embedded systems, connected devices, and/or IoT ecosystems.
• Experience applying threat modeling and vulnerability assessment frameworks such as STRIDE and CVSS.
• Experience conducting penetration testing, malformed input testing (fuzz testing), static application security testing (SAST), and/or dynamic application security testing (DAST) for embedded systems.
• Experience performing software composition analysis (SCA), software bill of materials (SBOM) generation, SBOM monitoring, and related software security activities.
• Experience applying C programming language concepts and/or cryptographic principles to support product cybersecurity activities.
• Experience communicating cybersecurity risks, technical findings, and recommendations through verbal discussions, presentations, and written communications.
• Experience managing multiple projects, priorities, and deliverables across cross‑functional teams in a dynamic product development environment.
• Experience working with internal stakeholders and external business partners to support cybersecurity, compliance, and product development initiatives.

• Ten (10) years of cybersecurity and/or cybersecurity risk management experience supporting medical devices.

• Work location:
  
  Remote (United States).
• Travel:
  May include up to 5% domestic/international.
• Relocation Assistance:
  May be authorized.
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

• Applicable to US Applicants Only:
  The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position.
• In addition, this position may…