Integra LifeSciences · 7 hours ago
Medical Device Security Engineer
US-NJ-Princeton-100-Headquarters
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expIntegra LifeSciences is a company focused on improving healthcare outcomes through innovative solutions. They are seeking a Medical Device Security Engineer to perform risk analysis on cybersecurity threats, implement security controls, and collaborate with development teams to enhance product security.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Perform risk analysis on product‑related cybersecurity risks, determine required security controls, and manage residual risk for security‑related product threats
Model Product Security Threats and continuously monitor global product‑related cybersecurity threats
Conduct and document CIS (Center for Internet Security) Benchmark / Baseline reviews for relevant systems and embedded platforms to ensure compliance with hardened configuration requirements
Ensure adherence to recognized Medical Device Cybersecurity Frameworks, including (but not limited to): FDA Pre‑ and Post‑Market Cybersecurity Guidance, AAMI TIR57 & AAMI TIR97, ANSI/AAMI SW96, IEC 81001‑5‑1 (Health Software & Health IT Security), IEC 62443 (Industrial & IoT Security where applicable), ISO 14971 (Risk Management) as applied to security‑induced safety risks
Research and advocate for new security solutions, technologies, and architecture patterns to improve product cybersecurity posture
Collaborate with development teams to integrate secure coding and secure design practices into the software and hardware development lifecycle
Collaborate with Quality and Regulatory functions to ensure proper evaluation and documentation of safety risks induced by security risks, aligning with medical device safety regulations
Implement and manage security tools and technologies that strengthen the security posture of applications, embedded systems, and connected medical devices
Provide technical cybersecurity guidance, mentorship, and support to engineering teams, leadership, and cross‑functional stakeholders
Support vulnerability management activities, including SBOM reviews, vulnerability scanning, penetration testing coordination, and remediation planning
Ensure product designs incorporate secure configuration, hardening, encryption, authentication, authorization, secure update mechanisms, and secure logging principles
Participate in internal and external cybersecurity assessments, audits, and regulatory submissions (FDA, EU MDR, Notified Bodies)
Develop and maintain cybersecurity documentation, including threat models, risk assessments, secure‑by‑design documentation, security test plans, and postmarket surveillance artifacts
Qualification
Required
At least 10 years of experience in the Information Security or Cybersecurity domain
Certification(s) from recognized cybersecurity organizations (e.g., ISC², ISACA, GIAC)
Experience as a Security Regulation and Standards Engineer/Manager
Experience in systems engineering and collaborative development environments
Experience preparing cybersecurity documentation for regulated industries
Knowledge of Information Security and Cybersecurity Standards, Methodologies, and Controls, including CIS Benchmarks, NIST Cybersecurity Framework, OWASP, and secure development methodologies
Knowledge and hands-on experience in product development and system engineering processes across hardware, firmware, and software
Strong understanding of medical device cybersecurity requirements, secure architecture patterns, threat modeling (STRIDE, attack trees), and product lifecycle security
Familiarity with secure boot, cryptography, embedded system hardening, secure communication protocols, and resilience techniques
Preferred
Experience working in regulated industries (Medical Device, Avionic) – advantage
Academic degree in Computer Science, Software Engineering, Electrical Engineering, or equivalent work experience – advantage
Experience in Software and/or Hardware development – advantage
Experience applying medical cybersecurity frameworks such as IEC 81001‑5‑1, AAMI TIR57, AAMI TIR97, ISO 14971, and/or IEC 62443 – strong advantage
Preferred industry certifications such as: CISSP, CSSLP, CEH, GICSP, GCSD, CCSP – advantage
Medical-device-relevant credentials (e.g., HCISPP, CISA, GIAC IoT Security) – advantage
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences 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 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
2026-01-23
Company data provided by crunchbase