Medical Product Security Specialist

Overview

FUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment. Fujifilm’s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. The Synapse® Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record. REiLI®, Fujifilm’s artificial intelligence initiative, combines Fujifilm’s rich image -processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more information, please visit .

External US

Job Title: Medical Product Security Specialist

Job purpose

This position will report to the Director of Security and Privacy and be responsible for driving compliance with standards for medical device product security, and analyzing, planning and documenting collaboration with product development to develop secure medical devices. This position requires a strong background in medical device cybersecurity and FDA product cybersecurity, with experience in threat modeling, creating data flow and security architecture diagrams. Excellent communication and problem-solving skills are essential for this role.

Duties and responsibilities

Ensuring the security of our medical devices and systems, software, and hardware. Advising on cybersecurity testing deliverables, threat modeling and designing architecture diagrams to identify potential vulnerabilities and develop robust security measures. Collaborates with Director of Security and Privacy on assignment prioritization and remediation activities; and executes plan with the development teams. Likely to assist in management of product penetration testing and remediation tracking. Likely to assist in response to customer questionnaires for risk assessment or sales inquiries. Manage incorporating lessons learned from security incidents into product requirements. Stay current on IT security trends and news. Assist in uplifting company-wide culture of best practices for stewardship of confidential data privacy and security. Research security enhancements and make recommendations to management. Other duties as assigned by the Director of Security and Privacy.

Qualifications

A bachelor's degree in computer science or related field or equivalent work experience in the Information Technology industry. CISSP, CCSP, CompTIA Security +, GSEC, CCST, and industry cyber security experience, or able to attain one within 1 year of being hired. 2-4 years of work experience with medical device cyber security configuration requirements (FDA Cybersecurity Guidance, CIS Benchmarks / HIPAA Security Rules / NIST), testing and remediation management. Experience in information security / cybersecurity for medical devices and software related to HIPAA controls. Understanding of firewalls, proxies, SIEM, IDS/IPS, GRC, antivirus, and server/network hardening. Ability to understand application of security frameworks to medical devices, support business schedules against security requirements, identify and mitigate risks and present options to stakeholders from other departments. Understanding vulnerability/patch management and develop educational content in a timely manner. Experience working in security management of Medical Device(s), Medical Software and/or Data Hosting, supporting medical software or hardware. Real life medical device industry experience with proven understanding of security requirements and management through a medical device lifecycle – from design through end of support.

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

The ability to sit up 75-100% of applicable work time. The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time. The ability to stand, talk, and hear for 75% of applicable work time. The ability to lift and carry up to ten pounds up to 20% of applicable work time. Close Vision: The ability to see clearly at twenty inches or less.

Travel

Occasional (up to 10%) travel may be required based on business need.

Equal Opportunity Employer

FUJIFILM is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.

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