Senior Cybersecurity Professional
1 week ago
We are seeking a cybersecurity expert to lead and support compliance with software development regulations across our Total Artificial Heart system software and associated digital technologies.
The ideal candidate will be passionate about patient safety, quality systems, and secure product design.
This role will spend approximately 80% of time supporting software and cybersecurity quality engineering activities globally and around 20% on broader quality assurance tasks, including document control, CAPA, change control, supplier control, and audit readiness.
Key Responsibilities- Support the secure software development lifecycle (SDLC) and risk management processes per IEC 81001-5-1, FDA Premarket Cybersecurity Guidance, and ISO 14971.
- Review and approve software development documentation, including threat modeling, architecture, verification protocols, configuration management, and software bills of materials (SBOM).
- Collaborate with software and systems engineers to ensure secure-by-design product development.
- Participate in vulnerability assessment, penetration testing, and third-party risk management activities.
- Maintain cybersecurity risk assessments, controls, and traceability matrices.
- Ensure that design and process changes maintain a robust cybersecurity posture throughout the device lifecycle.
- Support audit and regulatory submissions related to software and cybersecurity compliance.
- Participate in document control, training, and change control activities.
- Support CAPA investigations and root cause analysis.
- Assist with internal and external audits and inspection readiness.
- Help ensure compliance with FDA QSR, ISO 13485, ISO 14971, and other applicable standards.
- Support the receiving and inspection of materials and components for quality conformance.
- Assist with identifying and documenting nonconforming products and supporting investigations.
- Contribute to supplier evaluations and support follow-up on quality-related issues.
- Assist in managing quality records, design history files, and change control documentation.
- Support process validation activities, facility controls, and ensure adherence to good documentation practices.
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