Overview
Skills
Job Details
Danvers MA
Job Description:
>> 12+ years of professional experience, with over 5 years dedicated to medical device cybersecurity and regulatory compliance.
>> Strong background in embedded systems development using C and C++ within the medical device sector.
>> Specialized in deploying robust security controls for medical devices, including secure authentication, authorization mechanisms, device connectivity, secure boot, and bootloader integration.
>> 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.
>> 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.
>> Hands-on experience in penetration testing, Software Bill of Materials (SBOM) analysis, and vulnerability management.
Requirements:
>> Cybersecurity experience in medical device domain is mandatory