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Cybersecurity Software Engineer
3 weeks ago
We are seeking a highly skilled Software Quality Engineer to lead and support cybersecurity and software development compliance 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.
Key Responsibilities- Support secure software development lifecycle (SDLC) and risk management processes per IEC 62304, 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.
- Bachelor's degree in software engineering, computer science, biomedical engineering, or related technical discipline.
- Minimum 7 years of experience in software quality engineering, cybersecurity, or a regulated software development environment.
- Strong working knowledge of IEC 62304, ISO 14971, and current FDA and international cybersecurity guidance.
- Familiarity with cybersecurity risk management frameworks (e.g., NIST, ISO).
- Experience reviewing technical documentation for medical or safety-critical software.
- Excellent written and verbal communication skills.
Our company offers a comprehensive benefits package, including medical, dental, and vision insurance, as well as short-term and long-term disability coverage.
Employees also enjoy generous vacation time and paid time off policies, as well as access to a 401(k) plan with employer match.
Additionally, we offer incentives and rewards for meeting performance goals and exceeding expectations.
Our company is committed to creating a diverse and inclusive work environment and welcomes applicants from all backgrounds.
