Cybersecurity Engineer

Job Description
The Cybersecurity Engineer will conduct targeted gap assessments and remediation for cybersecurity elements within Design Inputs, Design Outputs, Verification & Validation (V&V), and Risk Management. The role ensures that the medical device complies with FDA cybersecurity guidance and IEC 81001-5-1 standards. The engineer will work closely with cross-functional teams to integrate cybersecurity controls across the product lifecycle and support secure product development and release.

Required Skills
Threat modeling methodologies (e.g., STRIDE)
Vulnerability assessment and risk analysis for software/connected devices
Secure Software Development Lifecycle (SSDLC)
Penetration testing and security validation strategies
Cybersecurity requirements and design controls documentation
Medical device cybersecurity gap remediation

Required Qualifications
Bachelor's degree in Cybersecurity, Computer Engineering, or related field
Experience with FDA cybersecurity guidance for medical devices
Strong knowledge of IEC 62304 and ISO 14971
Familiarity with IEC 81001-5-1 standard
Experience working within medical device regulatory environments

Additional Skills
Knowledge of AAMI TIR57, AAMI TIR97, and AAMI SW96
Certifications such as CISSP, CISM, or equivalent (preferred)
Experience preparing cybersecurity risk management reports
Exposure to Design Transfer and manufacturing security controls
Ability to collaborate across engineering, QA, and regulatory teams

Interview Process
Technical screening on cybersecurity fundamentals and medical device standards
In-depth discussion on threat modeling and risk management experience
Practical or scenario-based evaluation on cybersecurity gap remediation
Final interview with cross-functional stakeholders

Additional Notes
Strong emphasis on regulatory compliance and documentation
Role requires both technical depth and process-oriented mindset
Prior experience in regulated medical device environments is critical