**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Cybersecurity Software Engineer based in United States.** As a Cybersecurity Software Engineer, you will play a key role in developing secure software solutions for innovative diagnostic technologies within a highly regulated environment. Working at the intersection of software engineering, cybersecurity, quality, and regulatory compliance, you will help ensure products are designed with security at their core throughout the entire development lifecycle. This position offers the opportunity to collaborate with multidisciplinary teams, influence system architecture, and contribute to products that improve healthcare outcomes. Ideal for professionals with strong technical expertise and regulatory knowledge, this role combines secure software development with compliance, risk management, and continuous innovation in a collaborative engineering environment. ### Accountabilities: - Integrate cybersecurity requirements into the design and development of embedded software for diagnostic platforms, ensuring secure-by-design implementation. - Collaborate with software engineering teams to incorporate cybersecurity best practices throughout the software development lifecycle. - Ensure compliance with applicable cybersecurity regulations, including FDA pre-market and post-market guidance and other North American regulatory requirements. - Translate cybersecurity, quality, and regulatory requirements into clear technical specifications and engineering documentation. - Contribute to and maintain Design History File (DHF) documentation while supporting design control and product development processes. - Support software lifecycle activities in accordance with IEC 62304 and participate in product development reviews. - Perform cybersecurity risk management activities, including threat modeling, vulnerability assessments, risk analysis, and mitigation planning in alignment with ISO 14971. - Review software and system architecture to ensure alignment with secure development principles and industry best practices. - Serve as a cross-functional liaison between engineering, quality, regulatory, and research teams to facilitate secure and compliant product development. - Support additional engineering initiatives and participate in occasional international travel as required. ## Requirements - Bachelor's or Master's degree in Software Engineering, Computer Engineering, Computer Science, or a related technical field. - Minimum of 5 years of experience in software engineering or system-level engineering roles. - Recent hands-on experience in cybersecurity, preferably within medical devices or another highly regulated industry. - Strong knowledge of FDA cybersecurity guidance for medical devices, including pre-market and post-market requirements. - Solid understanding of IEC 62304 software lifecycle processes and ISO 14971 risk management principles. - Experience working with regulated design documentation, including Design History Files (DHF) or equivalent technical documentation. - Experience integrating software and hardware systems in complex product environments. - Familiarity with cybersecurity practices such as threat modeling, vulnerability assessment, and security risk management. - Excellent analytical, communication, and cross-functional collaboration skills with the ability to communicate complex technical and regulatory concepts. - Ability to travel internationally up to 10–15% of the time. ### Preferred Qualifications - Previous experience in a Software Lead or Technical Lead role. - Familiarity with Laboratory Information Systems (LIS), connected medical devices, or IoT technologies. - Knowledge of cybersecurity standards and frameworks such as AAMI TIR57, AAMI TIR97, IEC 81001-5-1, the NIST Cybersecurity Framework, and OWASP. - Basic proficiency in French or Korean. ## Benefits - Competitive compensation package. - Opportunity to contribute to innovative healthcare and diagnostic technologies. - Collaborative, multidisciplinary engineering environment. - Exposure to advanced cybersecurity and regulated product development practices. - Professional growth through cross-functional projects and technical leadership opportunities. - International collaboration with occasional travel. - Inclusive workplace committed to equal opportunity and diversity. **How Jobgether works:** We use an **AI-powered matching process** to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! [Why Apply Through Jobgether?](https://jobgether.com/how-jobgether-works) **Data Privacy Notice:** By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1