Principal Cybersecurity Assurance Engineer

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee cybersecurity assurance initiatives throughout the entire product life cycle.

• Develop cybersecurity risk management strategies and documentation.

• Conduct threat modeling and vulnerability evaluations.

• Establish security architecture and implement security controls.

• Generate and oversee software bills of materials (SBOMs).

• Handle vulnerabilities and cybersecurity risks effectively.

• Organize and supervise security testing efforts, including penetration testing.

• Ensure alignment between security controls, security requirements, and security testing activities.

• Maintain compliance with regulatory mandates and industry benchmarks.

• Report significant issues impacting patient safety, cybersecurity, customer experience, or adherence to processes.

• Serve as a cybersecurity advocate within product development teams.

• Evaluate system designs for vulnerabilities and assess cyber risk profiles.

• Collaborate with hardware and software engineers, Design Assurance, Quality, and Regulatory teams.

• Assist in meeting cybersecurity regulations and prepare for ATO readiness.

• Work alongside security teams to monitor and respond to cyber threats.

• Facilitate process enhancements, external audits and submissions, CAPA, supplier audits, and quality-related cybersecurity operations.

• Guide, mentor, and coach cybersecurity assurance engineers.

⛳️ Requirements

• A Bachelor’s degree or higher (must be completed and verified before starting).

• A minimum of eight (8) years in cybersecurity and/or cybersecurity risk management experience related to medical devices.

• Experience with embedded systems, Internet of Things (IoT) devices, Bluetooth, Wi-Fi, and/or cellular technologies.

• Familiarity with premarket and postmarket medical device regulations and standards, including FDA requirements, EU regulations, IEC 81001-5-1, ISO 13485, ISO 14971, IEC 62304, or similar standards.

• Proven track record in leading and documenting threat modeling and vulnerability assessments for embedded systems, connected devices, and/or IoT ecosystems.

• Experience utilizing threat modeling and vulnerability assessment frameworks such as STRIDE and CVSS.

• Background in conducting penetration testing, malformed input testing (fuzz testing), SAST, and/or DAST for embedded systems.

• Experience with software composition analysis (SCA), software bill of materials (SBOM) generation, SBOM monitoring, and related software security practices.

• Proficiency in C programming language concepts and/or cryptographic principles.

• Strong communication skills for conveying cybersecurity risks, technical findings, and recommendations both orally and in writing, including presentations.

• Ability to manage multiple projects, priorities, and deliverables across various functional teams.

• Experience collaborating with internal stakeholders and external business partners.

• Must possess legal authorization to work in the country of employment without sponsorship for a work visa.

🏝️ Benefits

• Medical, Dental & Vision coverage.

• Health Savings Accounts.

• Health Care & Dependent Care Flexible Spending Accounts.

• Disability Benefits.

• Life Insurance.

• Optional Voluntary Benefits.

• Paid Time Off.

• Retirement Benefits.

• Variable incentive pay, if eligible.

• Relocation Assistance may be provided.