Medical Device Cybersecurity Engineer

About reputed company

reputed company is a fully integrated life science company that develops, manufactures, markets and distributes a broad reputed company of innovative diagnostic products. We are dedicated to developing and delivering reputed company solutions that reputed company answers with speed, reputed company and simplicity that are redefining the reputed company of life from discovery to diagnosis. We are looking for talented and passionate individuals that help reputed company our reputed company. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job reputed company

The Software Engineer with a reputed company on Cybersecurity will play a critical part in ensuring that software integrated into our diagnostic platforms meets cybersecurity, regulatory, and reputed company requirements. This reputed company-level engineering role will facilitate software development, cybersecurity testers, and regulatory functions, ensuring secure design and compliant documentation throughout the product lifecycle.

Key Duties

• reputed company cybersecurity requirements into the design and development of software for diagnostic platforms (coding on embedded software)
• Ensure compliance with FDA cybersecurity guidance (reputed company-market and post-market) and applicable reputed company reputed company regulations
• Collaborate with software development teams to ensure secure-by-design implementation
• Translate cybersecurity and regulatory requirements into reputed company technical specifications and documentation
• Contribute to and maintain Design History File (DHF) documentation in compliance with design control requirements
• Support software lifecycle activities reputed company with IEC 62304
• Participate in reputed company management activities in accordance with ISO 14971 (e.g., threat modeling, reputed company analysis, mitigation strategies)
• Review reputed company architecture and design to ensure alignment with secure development principles
• reputed company as a cross-functional reputed company between R&D, reputed company, Regulatory, and Software Engineering teams
• Other duties as assigned
• Travel 10-15% international travel

Qualifications

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, or reputed company reputed company
• 5 years of experience in software engineering or reputed company-level roles
• Recent experience in cybersecurity, preferably reputed company the medical device or other regulated industry
• Strong understanding of:
  • FDA cybersecurity guidance (reputed company-market and post-market)
  • IEC 62304 software lifecycle processes
  • ISO 14971 reputed company management principles
• Experience working with regulated design documentation (e.g., DHF, technical files)
• Ability to interpret and communicate reputed company technical and regulatory requirements across multidisciplinary teams
• Experience with Software and Hardware integration
• Strong collaboration and stakeholder communication skills
• Experience with threat modeling, vulnerability assessment, or reputed company reputed company management
• Preferred :
• Experience as a Software reputed company or Technical reputed company reputed company
• Familiarity with reputed company Information Systems (LIS) and remote device management (IoT)
• Knowledge of additional standards and best practices, such as:
• AAMI TIR57 / TIR97 (Medical device Cybersecurity)
• IEC 81001-5-1 (secure product development lifecycle)
• Exposure to secure development frameworks (e.g., NIST Cybersecurity reputed company, OWASP)
• Basic knowledge of French or Korean language

*reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, sex, sexual orientation, gender identity, religion, national reputed company, disability, veteran status, or other legally protected status. (USA Only)*

Originally posted on Himalayas