Software Engineer in Test- Pleasanton, CA
CalyxoPleasanton, California, United States · Posted 24 days agoDescription
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 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
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