About Evident Digital Pathology
Evident Scientific, formerly part of Olympus Corporation, is a global leader in life-science microscopy and optical instrumentation. Following the recent acquisition of Pramana, a pioneer in Autonomous Digital Imaging, Evident has combined its world-class optical heritage with Pramana’s software, robotics, and AI innovation to define the future of Digital Pathology.
Our young, high-performing engineering team has already taken the industry to its next node in autonomy—building the world’s most advanced whole-slide imaging platform, deployed at the Mayo Clinic to create the world’s largest digital pathology archive. Today, this technology is trusted by more than 30 top-tier medical institutions across the U.S. and Europe, powering Clinical workflows directly aiding in patient care.
As part of Evident, this team is now advancing to the next level of autonomy—moving from autonomous imaging to intelligent imaging, where scanners, data systems, and user interfaces are self-aware, adaptive, and capable of real-time AI inference at the edge.
About The Role:
We are seeking a highly skilled and experienced Cybersecurity Professional to join our team.
This role is critical in ensuring that our digital pathology solutions meet regulatory requirements and maintain the highest standards of cybersecurity. The ideal candidate will have a deep understanding of medical device cybersecurity, regulatory compliance, and quality management systems, particularly in the context of FDA, CE Mark, and US Federal Government
requirements.
Key Responsibilities:
Regulatory Compliance:
- Ensure compliance with FDA cybersecurity guidelines for medical devices, including risk management and mitigation strategies.
- Prepare and maintain technical documentation required for CE marking under the EU MDR.
FDA 510(k) Submission:
- Ensure all necessary documentation for 510(k) submissions, including a description of the device's security features and risk management approach, is prepared and submitted.
- Collaborate with regulatory affairs to demonstrate substantial equivalence to legally marketed devices, facilitating market clearance.
Risk Management:
- Conduct comprehensive risk assessments to identify potential cybersecurity threats and vulnerabilities.
- Develop and implement risk mitigation strategies to protect our digital pathology systems.
Quality Management System (QMS):
- Integrate cybersecurity best practices into our ISO 13485 certified QMS.
- Develop and maintain cybersecurity policies and procedures in line with ISO 13485 standards.
- Support internal and external audits by providing evidence of cybersecurity measures and their effectiveness.
Continuous Monitoring and Incident Response:
- Implement continuous monitoring processes to detect and respond to cybersecurity incidents promptly.
- Develop and maintain incident response plans to address and mitigate the impact of cybersecurity breaches.
Collaboration and Training:
- Work closely with cross-functional teams, including product development, IT, and regulatory affairs, to ensure cybersecurity is considered at every stage of the product lifecycle.
- Provide cybersecurity training and awareness programs for employees to foster a culture of security.
Qualifications:
Bachelor’s degree in Computer Science, Information Security, or a related field; advanced degree preferred.
Minimum of 3 years of experience in cybersecurity, preferably in the medical device or healthcare industry.
In-depth knowledge of FDA cybersecurity guidelines, EU MDR requirements, and US Federal Government cybersecurity standards.
Experience with ISO 27001 and integrating cybersecurity into QMS.
Proven track record of successfully navigating the Compliance process.
Strong understanding of risk management principles and methodologies.
Excellent problem-solving skills and attention to detail.
Strong communication and collaboration skills.