Principal Software Engineer

About the position

Veranex has an exciting opportunity to join our team as a Principal Software Engineer. The ideal candidate will have a background in cybersecurity, and will be responsible for organizing and coordinating activities for clients to help identify and meet quality management systems (QMS) needs. In addition, evaluates design inputs and design changes for requirements, risk management and impact assessment, collaborates with clients to assure risk, or other management plans for design, production and maintenance processes for general and specific product performance needs are established, while ensuring these activities are in accordance with industry standards and regulations.

Responsibilities

• Leads software maintenance, including software patches and software updates by verifying that all appropriate documentation is established, reviewed, and revised appropriately, including assuring new features have been properly specified and tested and regression testing of devices has been performed to assure continued safety and effectiveness after changes have been implemented.
• Performs and documents development activities such as requirements analysis, use case development, and risk management performed to ensure device verification and validation is complete, the product is safe and of high quality, and that documentation and product meet all regulatory requirements.
• Oversees the administration of device design and change control and works with clients to assure design control and design change activities meet requirements and timeline and assists them with the development and review of software lifecycle management documentation.
• Leads and supports software testing and traceability activities to assure continued safety and effectiveness after changes have been implemented and ensures they meet all requirements.
• Facilitates the development of software requirements for off-the-shelf (OTS) software/ software of unknown provenance (SOUP) and cybersecurity and security documentation and ensures that they meet all internal quality system and regulatory requirements.

Requirements

• Bachelor's or Master's degree in software engineering or life sciences
• 5-8+ years of relevant experience in medical devices
• Experience mentoring junior engineers
• Experience functioning as a key decision maker on client projects
• In-depth knowledge of medical device regulations and standards
• In-depth knowledge of medical device regulations, guidance documents and standards (i.e., quality system regulations (QSR) International Organization for Standardization (ISO) 13485, ISO 14971, ISO 62304, related ASTM, ANSI, AAMI, TIR standards and guidance documents as needed)
• In-depth knowledge of off-the-shelf (OTS) software and software of unknown provenance (SOUP) requirements, cybersecurity design, testing and maintenance process.
• In-depth understanding of full product lifecycle for a medical device and an understanding of the differences between product lifecycles for traditional programmable electrical medical systems (PEMS) devices vs. software as a medical device (SaMD)
• In-depth understanding of automated testing frameworks
• Advanced computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms