
Chief Security Architect
1 day ago
We are seeking a highly skilled professional to lead cybersecurity and software quality engineering efforts in the development of medical device software. The successful candidate will have strong expertise in risk management, threat modeling, and secure software development practices.
This role requires collaboration with cross-functional teams to ensure that our products meet the highest standards of quality, safety, and regulatory compliance. The ideal candidate will have excellent communication skills, be able to work independently, and have a strong understanding of industry regulations and standards.
Key Responsibilities:
- Risk management and threat modeling to identify potential vulnerabilities in our software
- Review and approval of software development documentation to ensure compliance with regulatory requirements
- Collaboration with software engineers to ensure secure-by-design product development
- Participation in vulnerability assessment, penetration testing, and third-party risk management activities
- Maintenance of cybersecurity risk assessments, controls, and traceability matrices
- Support for audit and regulatory submissions related to software and cybersecurity compliance
Required Skills & Qualifications:
- Bachelor's degree in software engineering, computer science, or related technical discipline
- Minimum 7 years of experience in software quality engineering, cybersecurity, or regulated software development environment
- Strong working knowledge of IEC 62304, ISO 14971, and current FDA guidelines
- Familiarity with cybersecurity risk management frameworks (e.g., NIST, ISO 27001)
- Experience reviewing technical documentation for medical or safety-critical software
PREFERRED QUALIFICATIONS:
- Class III medical devices or implantable systems experience
- IPEC 81001-5-1, UL 2900, or FDA Premarket Cybersecurity Final Guidance familiarity
- Hands-on experience with software testing, threat modeling, SBOM tools, or vulnerability analysis
We offer a dynamic and collaborative work environment, opportunities for professional growth and development, and a chance to make a meaningful contribution to the field of medical device software development.
The company is headquartered in Huntington Beach, CA, with an international office in Brisbane, Australia. Our team of experts includes biomedical engineers and cardiac surgeons who are passionate about developing innovative solutions for patients with end-stage heart failure.
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