The Opportunity

You will work directly with the Sr. Director of Production Engineering and will play an integral role in contributing towards the Company's future growth by leading and ensuring that the next generation of Universal DX's automation tools and pipeline software are robust, scalable, and aligned with security best practices.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

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This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

• Responsible for the overall cybersecurity excellence of our products.
• Collaborate with cross-functional team members to document, design, implement, and test safe, effective, and secure software in compliance with IEC 62304, ISO 14971, and FDA guidance for cybersecurity in medical devices.
• Develop, evaluate, and analyze software designs and trade-offs with a focus on cybersecurity.
• Conduct cybersecurity risk assessment activities, including threat modeling, vulnerability analysis, and analysis of mitigations.
• Develop and testing cybersecurity features and tools.
• Assist in the development of cybersecurity tests to verify and validate software compliance with defined requirements and specifications.
• Work with and assist other team members in offensive tecniques and approaches to asses the vulnerability and resilience of our software products and services.
• Provide recommendations of new security testing tools and techniques to improve the overall security excellence of our products and services.
• Analyze source code, test data, and security scan reports for vulnerabilities and suggest/implement mitigations.

What you'll bring

• Minimum bachelors degree in Computer Science, Computer Engineering, or other job-related field.

• Minimum 10+ years of experience developing software in complex medical devices for submission to FDA in languages including, but not limited to, C, C++, C#, Java, Javascript, or Python.
• Minimum 5+ years performing cybersecurity activities in alignment with FDA guidance for cybersecurity in medical devices.
• Minimum 3 years experience working in cloud environment related to medical data privacy and medical data security, especially HIPAA and 21 CFR Part 820 compliance.
• Strong knowledge of FDA guidance for cybersecurity in medical devices
• Strong knowledge and experience working with threat modeling techniques, secure coding, authentication and
authorization, software development, cryptography, network and application security
• Strong knowledge of OO design and industry best practices for software development.
• Certification in penetration testing, with OSCP cert or similar
• Knowledge of networking protocols such as HTTP, DNS, TCP/IP, FTP, etc
• Detail-oriented, self-motivated, and able to work independently in a fast-paced, dynamic environment.
• Excellent troubleshooting and communication abilities.

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