Software Engineer in Test- Pleasanton, CA

About this role

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

• 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.

Preferred Qualifications

• 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 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 We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment…