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.

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.

• 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

• Director, Software Engineering

• 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 understanding 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 hazardous materials, wearing protective equipment, etc.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

• Advanced knowledge of common Libraries and Frameworks (STL, Boost, Qt)
• Proficiency 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…