Manager, Systems and Test Engineering

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:

We're looking for a Manager of Systems and Test Engineering to lead the development of our next-generation endoscopic platforms. This is a hands-on leadership role where you'll guide a multidisciplinary team through system architecture, integration, and verification of complex medical devices that combine imaging, fluidics, sensors, and control systems. You'll play a critical role in ensuring our devices meet the highest standards of performance, safety, and regulatory compliance while helping shape the future of minimally invasive urology. This is an in-office position in Pleasanton, CA.

In This Role, You Will:

• Lead and Inspire: Manage and mentor a team of systems and test engineers working on advanced endoscopic technologies.
• Architect the Future: Oversee system-level design, requirements engineering, interface definition, and risk management throughout the product lifecycle.
• Own the Test Strategy: Develop and execute robust system-level verification plans aligned with FDA and ISO standards.
• Build Smart Tools: Lead test method development, including automated test equipment and simulated use protocols for both system and subsystem testing.
• Collaborate Cross-Functionally: Work closely with clinical, software, hardware, vision systems, and quality teams to ensure seamless system integration.
• Solve Complex Problems: Drive root cause analysis and resolution of system-level issues during development and testing.
• Ensure Traceability: Maintain clear traceability from requirements through design, implementation, and testing.
• Support Regulatory Success: Contribute to regulatory submissions and audits with high-quality technical documentation.
• Continuously Improve: Champion best practices in systems and test engineering processes, tools, and methodologies.

Who You Will Report To:

• See Organizational Chart

Requirements:

• Bachelor's or Master's degree in Biomedical, Electrical, Mechanical, or Systems Engineering.
• 8+ years of experience in systems and/or test engineering, with 3+ years in a leadership role within the medical device industry.
• Proven track record with complex mechanical and electromechanical systems-ideally in endoscopy or minimally invasive surgical devices.
• Deep knowledge of FDA QSR, ISO 13485, IEC 60601, and ISO 14971.
• Experience with tools like JAMA, DOORS, Polarion, TestRail, and LabVIEW.
• Strong leadership, communication, and cross-functional collaboration skills.
• Experience with optical systems, image processing, or video-based medical devices.
• Familiarity with embedded systems testing.
• INCOSE CSEP certification or equivalent (preferred).
• Experience with Agile development and model-based systems engineering (MBSE).
• 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 an attractive compensation package, which includes:

• A competitive base salary of $170,000 - $195,000 and variable incentive plan
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

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.

Disclaimer:

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.