Senior Quality Engineer, Sterilization & Biocompatibility - 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.

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:

• Director, Design Quality Assurance

Requirements:

• Bachelor’s degree in Engineering, Life Sciences/Microbiology, or related field.
• Minimum 6-8 years of experience in Class II medical device quality engineering, sterilization, biocompatibility, and associated packaging.
• Strong knowledge and experience with ISO 11135, ISO 10993, ISO 13485, and FDA QSR.
• Effective communication, collaborative attitude, and strong accountability mindset.
• Direct collaboration with external sterilization and biocompatibility test labs.
• Proficient in risk management tools and statistical analysis (e.g., Minitab).
• Strong communication, documentation, and cross-functional collaboration skills.
• ASQ CQE or related certification preferred.Travel: 5% domestic travel may be required
• Formal training in both ISO 11135 and ISO 10993 ideally preferred.
• Full time employment.
• Must be able to lift 10 pounds and sit for up to 8 hours/day.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.
• Hybrid 4 days/week onsite, 1 day remote.

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