Software Design Assurance Engineer
Company
Company
- High growth – Pre-IPO medical device start-up
- Well-funded
- Successful leaders with prior start-up success
- Ensure the quality and security of medical device software development throughout its life cycle
- This position requires a deep understanding of software assurance activities, including security risk assessment plans, and software bills of materials (SBOMs), vulnerability management, supporting SW defect tracking and resolution
- Design secure SW architectures, performing and supervising security testing, and monitoring vulnerabilities to ensure compliance with applicable regulatory requirements and industry standards
- Determine software safety classifications, test readiness, and release readiness, as well as in assessing the security risk profile for applicable devices
- Participate in the software development process, reviewing and approving software requirements, design documents, test procedures, and results maintaining traceability.
- 2-3 years of experience in medical device software or regulated industry is required
- Experience with embedded systems, and cellular technologies is required
- Working knowledge of premarket and post market medical device regulations (FDA, EU) and standards (ISO 13485, ISO 14971, IEC 62304, ANSI/AAMI SW96) is required
- Experience leading and documenting threat modeling and vulnerability assessments using frameworks like CVSS is preferred
- Experience conducting penetration testing and static analysis security testing (SAST)
- Knowledge in any one of the following: C/C++, C#, Python or similar high level programming language.
- Ensure the quality and security of medical device software development throughout its life cycle
- This position requires a deep understanding of software assurance activities, including security risk assessment plans, and software bills of materials (SBOMs), vulnerability management, supporting SW defect tracking and resolution
- Design secure SW architectures, performing and supervising security testing, and monitoring vulnerabilities to ensure compliance with applicable regulatory requirements and industry standards
- Determine software safety classifications, test readiness, and release readiness, as well as in assessing the security risk profile for applicable devices
- Participate in the software development process, reviewing and approving software requirements, design documents, test procedures, and results maintaining traceability.