Software Engineer in Test- Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:     A creative problem solver with the ability to think out of the box and a highly developed desire to deliver software to improve the lives of our patients. A strong developer with proven ability to follow through on software development and verification tasks from requirements analysis, prototyping, software architecture design, implementation and testing all the way to roll-out and operational support. A person who is completely comfortable in a structured and regulated environment, and who can move fluidly between writing production code and rigorously verifying it.   In This Role, You Will :   Contribute to design and development of test plans and protocols for software design verification, and execute and document verification activities, test reports and summary documentation   Participate in cross-functional requirements analysis and software risk management activities; contribute to definition and documentation of software requirements   Translate high-level software requirements into detailed and thoroughly documented software implementations   Write high-quality, high-performance C++ based software for real time Urology Software Applications for medical devices   Participate in design and code reviews; contribute to design verification activities to prove that the software correctly implements requirements   Contribute to design and implementation of automated testing and continuous integration processes   Ensure medical device software complies with applicable regulatory standards and that development documentation is developed in accordance with FDA guidance   Actively contribute to and collaborate on software-related system validation activities   Support creation of regulatory submission documentation and support audit-related activities   Support cross-functional team with product cybersecurity assessments   Collaborate with a cross-functional team of computer vision and electrical engineering specialists   Collaborate with program management to create accurate software project schedules   Mentor other engineers, provide architectural guidance, evaluate new technologies , and define and lead implementation of best practices   Drive best practices for establishing requirements from user feedback and identify gaps/improvement opportunities within the risk management process   Who You Will Report To:    Director, Software Engineering Requirements :   Bachelor’s degree in Computer Science , Engineering, Math or a STEM discipline and a minimum 3-5 years' experience. Alternatively, minimum of 6 years professional experience developing   software for products released to and used by customers   Advanced experience with C++ software development (3-5 years)   Deep und erstanding of software engineering principles such as object-oriented analysis and design, data structures, algorithms and software architecture   Strong experience with unit testing, module and integration testing   Extensive hands-on experience with the design verification process in medical device development   Expert-level knowledge of black- and white-box testing methods   Experience with risk management processes and thorough understanding of FMEA   Experience developing and implementing automated tests for software quality assurance purposes   Strong experience with Python   Experience working in a Linux based environment, specifically in a command line environment   Ability to identify , analyze and document complex problems through effective use of technical and interpersonal communication skills, and to take responsibility for and drive actions necessary to resolve issues   Ability to handle conflicting priorities through interpersonal, team, leadership, and negotiation skills   Excellent documentation skills paired with willingness to actively employ these skills   Excellent communication skills and ability to work independently and effectively within a team environment   Must be able to lift 10 pounds, sit for up to 8 hours/day, operate a vehicle, work with hazardou s materials , wearing protective equipment, etc.   Compliance with relevant county, state, and Federal rules regarding vaccinations.   Preferred Qualifications   Advanced knowledge of common Libraries and Frameworks (STL, Boost, Qt)   P roficiency with common build systems (Make, CMake , or similar)   Familiarity with cross-compilation best development practices   Understanding of the Linux operating system’s boot and startup processes   Experience with software version control systems, such as git and familiarity with best practices in a collaborative software development environment   Knowledge of CI/CD tools and practices, including automated testing and deployment   What Will Make You Stand Out:   Experience with image processing and machine learning algorithms   Knowledge of CUDA and GPU programming   Software Development for NVidia Jetson embedded systems   Experience with calibration and testing for computer vision imaging pipelines   Experience in model-based testing   Familiarity developing software in a medical device regulated environment   Strong understanding of applicable regulatory standards, e.g., IEC-62304, ISO- 13485 and ISO-14971   What W e O ffer :