Cybersecurity Software Engineer
New
USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum of 5 years of experience in software engineering or system-level engineering roles.
- Required Skills
- Cybersecurity
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.
- Ability to travel internationally up to 10–15% of the time.
Responsibilities
- 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.
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