Biocompatibility and Sterility Assurance Manager - Remote, USA

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:

The Biocompatibility and Sterility Assurance Manager is a hands‑on technical leadership role responsible for execution and oversight of biocompatibility, sterilization, and contamination control programs and activities for Calyxo products. This role is ideal for a seasoned biocompatibility, sterility and microbiology expert who thrives in an operational, execution‑focused environment while gradually building team leadership responsibilities.

The position serves as Calyxo’s primary subject‑matter expert for EO sterilization, sterility assurance, biocompatibility, microbiological testing, and contamination control, working closely with R&D, Operations, Quality, Regulatory, and external test labs and consulting services.

In This Role, You Will:

• Serve as the primary technical owner for sterility assurance, biocompatibility, and environmental & microbial monitoring programs, including overall program development, management, maintenance, and execution.

• Oversee compliance and continuous improvement of sterility assurance and biocompatibility processes, testing strategies, execution, and documentation.

• Provide hands‑on technical leadership and execution over programs including bioburden, sterility, endotoxin, and EO residuals.

• Lead execution and review of EO sterilization validations, re-qualifications, and repeatability studies with external sterilization service providers.

• Serve as the primary interface to sterilization, biocompatibility, and microbiology suppliers and laboratories, driving schedules, deliverables, and issue resolution.

• Execution of testing, validation, and documentation activities within functional scope.

• Subject-matter expert and decision authority within functional scope.

• Accountable/responsible for issue resolution impacting compliance & supply continuity within functional scope.

• Support manufacturing transfers, alternate site qualifications, and supplier changes from a sterility and microbiology perspective.

• Partner closely with R&D, Operations, Quality and Regulatory in execution against aggressive timelines and resolving urgent issues as they arise related to functional areas.

• Support R&D, Operations, Quality and Regulatory with sterility, biocompatibility, and microbiology related technical assessments and risk evaluations as needed.

• Author, review, and approve sterility, biocompatibility, and microbiology related protocols, reports, rationales, and technical documentation.

• Ensure compliance with applicable standards and regulations including ISO 14937, ISO 11135, ISO 11737, ISO 10993, and FDA QMSR.

• Support regulatory submissions, inspections, and audit activities related to functional areas

• Provide mentoring and technical guidance to the organization and cross-functional team members.

Who You Will Report To:

• Vice President, Quality

Requirements:

• Bachelor’s degree in Microbiology, Biology, Biomedical Engineering, or related scientific discipline.

• 10+ years of hands‑on experience in microbiology, biocompatibility, sterility assurance, or sterilization validation within the medical device industry.

• Strong knowledge and experience with ISO 14937, ISO 11135, ISO 11737, ISO 10993, and FDA QMSR.

• Strong practical experience with EO sterilization processes and external sterilization vendors.

• Demonstrated experience supporting FDA Class II or Class III sterile medical devices.

• Working knowledge of microbiological testing, contamination control, and EO residual requirements.

• Comfortable operating in a highly hands‑on, execution‑focused role within a growing organization.

• Strong communication, documentation, and cross-functional collaboration skills and strong accountability mindset.

• Direct collaboration with external outside labs and consulting services within functional scope.

• Formal training in ISO 14937, ISO 11135, ISO 11737, ISO 10993 ideally preferred.

• Travel: 5% domestic travel may be required.

• 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 range of $180,000 - $220,000 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 [email protected]. If you receive a request for information from any other domain, please contact us directly at [email protected] 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.