What are the responsibilities and job description for the Senior Software Quality Assurance Engineer - Pleasanton, CA position at Calyxo?
Job Description
Job Description
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.
In This Role, You Will :
- Assume responsibility for all software quality assurance activities in accordance with Quality System Requirements
- Ensure that medical device software complies with all applicable regulatory standards and that software development documentation is developed in accordance with FDA guidance
- Design and develop test plans and protocols for software design verification
- Execute and document software design verification activities, create and submit test reports and summary documentation
- Participate in cross-functional requirements analysis, software risk management activities and contribute to definition and documentation of software requirements
- Actively contribute to and collaborate on all software related system validation activities
- Contribute to design and implementation of automated testing and continuous integration process
- Support creation of regulatory submission documentation and support audit related activities
- Support cross-functional team with product cybersecurity assessments
- Drive best practices for establishing requirements from user feedback
- Identify gaps / improvement opportunities within risk management process
Who You Will Report To :
Requirements :
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
