Overview
Remote
Depends on Experience
Contract - W2
Contract - Independent
Contract - 1 Year(s)
Skills
Embedded Systems
Authentication
Authorization
Bill Of Materials
C++
Cyber Security
C
FOCUS
ISO 9000
JD
Medical Devices
Penetration Testing
Regulatory Compliance
Risk Management
Security Controls
Vulnerability Management
Job Details
Title: .Principle Product Security Engineer-2
Location : Danvers, MA ( Look for Remote)
Note- Cybersecurity experience in medical device domain is mandatory
JD as below.
- Industry Experience: 12+ years of professional experience, with over 5 years dedicated to medical device cybersecurity and regulatory compliance.
- Technical Development: Strong background in embedded systems development using C and C++ within the medical device sector.
- Security Implementation Expertise: Specialized in deploying robust security controls for medical devices, including secure authentication, authorization mechanisms, device connectivity, secure boot, and bootloader integration.
- Cybersecurity Risk Management: Proven track record in identifying and mitigating security risks in accordance with international regulatory standards such as FDA (Pre-market and Post-market), EU MDR, Japan PMDA, and China NMPA.
- Regulatory Standards & Compliance: Deep understanding of global security standards and guidelines, including ISO, IEC, AAMI, NIST, FDA, IMDRF, and MDCG, with a focus on medical device-specific security requirements and controls.
- Additional Competencies: Hands-on experience in penetration testing, Software Bill of Materials (SBOM) analysis, and vulnerability management.
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