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 testingoverseeing 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:

• Bachelors 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 : 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 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 $135000 - $165000 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 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 onlyvalued but alsoprioritized. 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 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. If you receive a request for information from any other domain please contact us directly at 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.