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Medical Device Security Engineer

From Manager Directly:

Looking for this resource to bridge the gap between GRC & IT Security team.
Must have medical device creation background and previous healthcare industry experience due to the nature of the role.
Strong understanding of medical devices and how that are implemented into an organization, how to implement controls around them, etc.
Will be working with biomedical & 3 rd party risk management team.
Does not want candidates with backgrounds in biomedical/clinical engineering.
Must be security & governance focused and will participate in the requirements for new technologies being implemented.

Some Duties:

Contribute to a development of medical device asset inventory and associated collection of security information.
Assist in design and maintenance of medical device security event monitoring solution.
Establish and maintain channels of communication with medical device manufacturers on cybersecurity related matters.
Develop cybersecurity requirements for various medical devices.
Provide cybersecurity design recommendations for various products and technologies.
Contribute to the development, coordination, and execution of the cybersecurity risk advisory service for medical devices including maintenance of processes.
Other duties as assigned.

Requirements:

BA in Computer Science or related field is required or equivalent acquired through combination of education and experience.
Minimum of 5 years of experience in a related field.
Understands and ensures compliance with current and applicable US laws and regulations.
Understanding and working knowledge of NIST Cybersecurity Framework, FDA Pre Market and Post Market Cybersecurity Guidance, ISO 80001 (MDS(2)), ISO 2700x series.
Experience and deep understanding of Hazard Analysis of Medical Devices and application of cybersecurity to FMEA or SHA.
General understanding of Medical Device Design process.
In-depth knowledge of cybersecurity frameworks including but not limited to NIST CF, HITRUST CSF, ISO 27001.
CAPA Certification is nice to have, not required.