Senior Software Quality Engineer

at  Veranex Inc

Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.

QUALIFICATIONS:

• Bachelor’s degree in software engineering or life sciences.
• 2-4 years of relevant experience with medical devices
• Good 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)
• Good knowledge of off-the-shelf (OTS) software and software of unknown provenance (SOUP) requirements, cybersecurity design, testing and maintenance process.
• Strong 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)
• Good understanding of automation testing frameworks
• Strong computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms
  Senior Quality Engineer

REQUIRED SKILLS:

• Bachelor’s degree in software engineering or life sciences
• 4+ years of relevant experience in medical devices
• Experience mentoring junior engineers
• Experience functioning as a key decision maker on client projects in software quality.
• Strong knowledge of medical device regulations and standards
• Strong 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)
• Strong knowledge of off-the-shelf (OTS) software and software of unknown provenance (SOUP) requirements, cybersecurity design, testing and maintenance process.
• Strong 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)
• Strong understanding of automated testing frameworks
• Advanced computer science fundamentals including data structures, programming experience and an understanding of fundamental algorithms
  Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics

ABOUT THIS ROLE:

Veranex has an exciting opportunity to join our team as a Software Quality Engineer II or a Senior Software Quality Engineer. You will be part of a team working to improve lives globally through medical technology innovation. The Software Quality Engineer will be responsible for organizing and coordinating the quality activities for clients to help identify and meet quality engineering and quality management systems (QMS) needs. Evaluates design inputs and design changes for quality requirements, risk management and impact assessment. Collaborates with clients to assure quality, risk, or other management plans for design, production and maintenance processes for general and specific product performance needs are established to the client’s QMS while ensuring these activities are in accordance with industry standards and regulations.
Software Quality Engineer II

WHAT YOU WILL DO:

• Supports 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.
• Supports design team in performing and documenting development activities such as requirements analysis, use case development, and risk management performed to ensure that the device verification and validation is complete, the product is safe and that the quality system documentation and product meet all regulatory requirements.
• Administers device design and change control and performs quality engineering activities. Including working 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.

WHAT YOU WILL DO:

• Performs 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 quality systems documentation and product meet all regulatory requirements.
• Leads the administration of device design and change control and performs quality engineering activities. Including working 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.
• Supports software testing and traceability activities to assure continued safety and effectiveness after changes have been implemented and ensures they meet all internal quality system and regulatory requirements.
• Supports 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.