Biocompatibility and Sterility Assurance Manager - Remote, USA

Calyxo

15d • $180,000 - $220,000 • Remote

About The Position

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.

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.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees