Software Gigs

This is a hands-on product security role focused on threat modeling and cybersecurity risk management for medical devices and SaMD platforms. You'll conduct security risk assessments, build FDA submission documentation (510(k) files, risk management files, SBOMs), review security architecture, and maintain risk and vulnerability management plans. The role requires 5+ years of cybersecurity or product security experience, with strong preference for FDA documentation and regulated medical device background, and working knowledge of NIST frameworks, OWASP, and secure SDLC practices.

Lead compliance testing and product certification for a portfolio of medical devices, including developing test strategies, managing external laboratories and certification bodies, and ensuring products meet safety, EMC, wireless, and regulatory requirements. Oversee compliance documentation, support design reviews and risk management, and monitor evolving regulatory standards. Manage a team of compliance engineers, departmental budgets, and drive process improvements in testing efficiency. Requires 5–8+ years of medical device compliance/certification experience and a technical degree (Mechanical, Electrical, or Biomedical Engineering).