Fusion Life Sciences Technologies LLC · 12 hours ago
Cyber Security Engineer
Cleveland, OH
Contract
Onsite
Senior Level, Lead/Staff
8+ years expFusion Life Sciences Technologies LLC is seeking a Medical Device Cybersecurity Engineer responsible for ensuring compliance with FDA cybersecurity requirements for medical devices. The role involves supporting cybersecurity risk management activities throughout the device lifecycle and contributing to regulatory submissions and inspections.
Data ManagementLife SciencePharmaceuticalStaffing Agency
Hiring Manager
Vijaya Bandi
Responsibilities
Ensure compliance with FDA medical device cybersecurity requirements, including FDA Premarket Cybersecurity Guidance and FDA Postmarket Cybersecurity Guidance
Support cybersecurity content for 510(k) including:
Cybersecurity risk assessments
Threat model
Security architecture descriptions
Software Bill of Materials (SBOM)
Threat & Vulnerability Assessment
Maintain cybersecurity documentation within the Design History File (DHF) and Risk Management File (RMF)
Support FDA inspections, audits, and responses related to cybersecurity
Perform cybersecurity risk management activities in accordance with ISO 14971
Identify cybersecurity hazards that could lead to patient harm or device malfunction
Define and implement cybersecurity risk controls and verify their effectiveness
Ensure cybersecurity requirements are incorporated into design inputs, design outputs, and design verification and validation activities
Support secure design reviews and change control processes
Monitor and assess cybersecurity vulnerabilities affecting medical devices, including third-party and open-source software
Support coordinated vulnerability disclosure processes in alignment with FDA expectations
Participate in post-market surveillance, complaint handling, and CAPA activities related to cybersecurity
Support incident response activities and field corrective actions as needed
Evaluate and implement security controls, including:
Authentication and authorization
Encryption and key management
Secure boot and firmware integrity
Logging and audit trails
Conduct or support penetration testing, threat modeling, and security testing
Assess cybersecurity risks associated with cloud services, mobile applications, and networked medical devices
Review supplier documentation related to cybersecurity and SBOMs
Ensure supplier cybersecurity risks are documented and mitigated per quality system requirements
Qualification
Required
Bachelor's degree in Cybersecurity, Computer Science, Software Engineering, Electrical Engineering, or related field
Minimum 8 years of experience in cybersecurity, with experience in medical devices
Medical Embedded Devices
VAPT (Hardware, Firmware)
Design History File (DHF)
Risk Management File (RMF) Documentation
Threat Modeling
SAST
DAST
SBOM and SOUP Analysis
SCA
FDA Regulations
510K
ISO 13485
ISO 14971
Company
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive.
201-500 employees
H1B Sponsorship
Fusion Life Sciences Technologies LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (57)
2024 (95)
2023 (116)
2022 (135)
2021 (128)
2020 (133)
Funding
Current Stage
Growth StageLeadership Team
R
Rohith Kumar
Executive Partner
Company data provided by crunchbase