Senior Quality Engineer, Sterilization & Biocompatibility

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 are seeking a skilled Senior Quality Engineer to support the development and manufacturing of Class II medical devices, with emphasis on ISO 11135 (EtO sterilization), ISO 10993 (biocompatibility), and general ISO 13485 compliance. The ideal candidate will have hands-on experience in quality engineering, working closely with sterilization and biocompatibility test laboratories, and ensuring product safety and regulatory compliance throughout the product lifecycle.

In This Role, You Will :

• Develop, implement, and maintain sterilization validation protocols (e.g., EO, gamma, steam) in accordance with ISO 11135, ISO 11137, and related standards for Class II kidney stone removal device.
• Serve as the key point-person, subject matter expert for all things related to Sterilization and Biocompatibility at Calyxo.
• Lead biocompatibility assessments and testing strategies per ISO 10993 series and FDA guidance.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations.
• Proactively lead essential project management for Sterilization and Biocompatibility testing-overseeing test sample configuration, writing protocols, facilitating sample logistics, tracking test results, and writing reports. Collaborate with external labs to execute tests, interpret results, and author comprehensive reports that drive product safety and compliance.
• Partner with R&D, Regulatory, and Manufacturing to integrate quality requirements (sterilization, biocompatibility, packaging) into key new products changes and critical sustaining changes.
• Drive and share recurring updates on the statuses of sterilization of production lots to key stakeholders.
• Support regulatory submissions (e.g., 510(k), PMA, CE Mark) by providing sterilization and biocompatibility data and justifications.
• Conduct risk assessments, e.g., toxicological risk, extractables / leachables, and support hazard analyses.
• Drive microbiological and associated material risk management activities (hazard analysis, FMEA) as needed.
• Participate in supplier qualification, audits, and incoming inspection.
• Support internal / external audits and regulatory inspections.
• Lead CAPA investigations and drive continuous improvement initiatives.
• Support routine sterilization dose audits, sterilization validation, biocompatibility testing and scientific rationale.
• Review and approve sterilization and biocompatibility documentation for new product development and design changes.
• Participate in internal and external audits, ensuring compliance with applicable regulations and standards.

Who You Will Report To :

Requirements :

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 :

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued, but 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.

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 :

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