eInfochips (An Arrow Company) · 10 hours ago
Medical Device Cyber Security Engineer
Cleveland, OH
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $140K/yr
8+ years expeInfochips, an Arrow Company, is seeking a Medical Device Cybersecurity Engineer responsible for ensuring compliance with FDA cybersecurity requirements for medical device software and connected systems. This role involves supporting risk management activities throughout the medical device lifecycle and contributing to regulatory submissions and inspections.
AutomotiveConsumer ElectronicsHardwareHealth CareImage RecognitionSecuritySoftwareVideo
Hiring Manager
Raghuveer Singh
Responsibilities
Ensure compliance with FDA medical device cybersecurity requirements , including FDA Premarket Cybersecurity Guidance and FDA Post-market 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
Demonstrated knowledge of FDA medical device cybersecurity guidance
Demonstrated knowledge of ISO 13485 and ISO 14971
Experience with cybersecurity risk assessments and regulatory documentation
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
Benefits
Medical, Dental, Vision Insurance
401k, With Matching Contributions
Short-Term/Long-Term Disability Insurance
Health Savings Account (HSA)/Health Reimbursement Account (HRA) Options
Paid Time Off (including sick, holiday, vacation, etc.)
Tuition Reimbursement
Growth Opportunities
And more!
Company
eInfochips (An Arrow Company)
eInfochips, an Arrow company, is a leading global provider of product engineering and semiconductor design services.
1001-5000 employees
H1B Sponsorship
eInfochips (An Arrow Company) 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 (16)
2024 (20)
2023 (24)
2022 (26)
2021 (17)
2020 (43)
Funding
Current Stage
Late StageTotal Funding
unknown2018-01-02Acquired
Leadership Team
Sumit Sethi
CFO
Raj Sirohi
COO
Recent News
Morningstar.com
2026-01-07
GlobeNewswire
2026-01-07
Company data provided by crunchbase