Director, Facilities & Environmental, Health & Safety - 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:

The Director, Facilities & EHS is responsible for strategic leadership and oversight of all facilities operations, maintenance programs, and site‑level environmental and safety compliance to ensure a safe, reliable, and audit‑ready environment for the manufacturing of urological medical devices. In addition this role requires strong EHS experience and full ownership of site Environmental, Health, and Safety programs. This leader ensures a compliant and efficient environment supporting sterile and non‑sterile manufacturing in a highly regulated setting.

In This Role, You Will:
Facilities Leadership & Site Operations
* Oversee all facilities operations, including building systems (HVAC, compressed air, utilities, water systems), preventive maintenance, and vendor management.
* Ensure reliable operation of critical environments such as clean rooms, controlled manufacturing areas, metrology spaces, and laboratories.
* Lead facilities planning, budgeting, and execution of capital improvement projects, including expansions, equipment installations, and infrastructure upgrades.
* Maintain facility readiness for audits, inspections, and certifications (OSHA, FDA, ISO 13485, notified bodies, state and local agencies, customers).
* Manage security, access control, janitorial, and site services.
* Manage pest control program for all facilities per quality procedures. Environmental, Health and Safety
* Maintain compliance with environmental regulations related to chemical storage, hazardous waste, wastewater, and air emissions.
* Oversee waste streams common in urology device manufacturing (e.g., IPA, polymers, lubricants, sterilization residues, packaging materials).
* Manage hazardous waste vendors, manifests, and reporting.
* Lead sustainability initiatives focused on reducing waste from sterile packaging, plastics, and energy‑intensive processes.
* Develop and maintain EHS policies, procedures, and training tailored to manufacturing of urology devices (catheters, scopes, disposables, electromechanical systems).
* Conduct risk assessments, job hazard analyses, and ergonomic evaluations for assembly, cleanroom operations, and equipment handling.
* Lead incident investigations and drive corrective/preventive actions.
* Oversee industrial hygiene programs, including exposure monitoring for chemicals, adhesives, sterilants, and particulates.
* Manage emergency response programs, including spill response and medical emergencies. Medical Device & Urology‑Specific Responsibilities
* Ensure facilities and EHS programs align with FDA, ISO 13485, and GMP requirements for sterile and non‑sterile urology products.
* Support safe handling of materials commonly used in urology device manufacturing (e.g., IPA, silicone, hydrophilic coatings, lubricants, adhesives, biocompatible polymers).
* Partner with R&D and Quality to assess facility and EHS impacts of new product introductions, including device coatings, sterilization methods, and electromechanical components.
* Support audits and inspections from FDA, notified bodies, and customers.
* Contribute to risk management activities where EHS intersects with product safety, including ISO 14971 considerations. Leadership & Collaboration
* Serve as the site's subject‑matter expert for facilities and EHS.
* Provide coaching and training to employees, supervisors, and cross‑functional teams; lead safety committees and drive a culture of accountability and continuous improvement.
* Develop and maintain facilities and EHS metrics, dashboards, and reporting…