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 , anal…