Senior Software Quality Assurance Engineer - 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.

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:

• Director, Software Engineering

Requirements:

• Education: Bachelor’s degree is required, preferably in Computer Science, Engineering, Math or a STEM discipline. In addition, 5+ years of relevant experience, preferably in the medical device industry 
• Alternative, minimum of 7 years professional experience in software quality assurance for products released to and used by customers 
• Work location: Pleasanton, CA
• Travel: <10%
• Full time employment
• Extensive hands-on experience with design verification process in medical device development 
• Strong understanding of applicable regulatory standards, e.g., 21 CFR 820, IEC-62304, ISO-13485 and ISO-14971  
• Experience developing and implementing automated tests for software quality assurance purposes 
• Expert level knowledge of black- and white-box testing methods 
• Experience with risk management processes and thorough understanding of FMEA 
• Ability to identify, analyze and document complex problems through effective use of technical and interpersonal communication skills, take responsibility for and drive actions necessary to resolve issues 
• Ability to handle conflicting priorities through interpersonal, team, leadership, and negotiation skills 
• Desirable: Experience with calibration and testing for computer vision imaging pipelines
• Desirable: Experience in model-based testing
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

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 with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive base salary range of $145,000 - $171,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

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.