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 for leadership.
• Manage budgets, consultants, and external service providers.

Who You Will Report To:

• Vice President, People

Requirements:

• Education:
  
  Bachelor's degree in Engineering, Facilities Management, Environmental Science, Occupational Health & Safety, or a related field; or equivalent relevant work experience.
• 10+ years of experience in facilities management and/or maintenance operations, with required EHS leadership experience in manufacturing, preferably within a regulated industry such as medical devices, pharmaceuticals, biotechnology, or related life sciences.
• Strong knowledge of OSHA, EPA, and state/local regulatory requirements; experience with hazardous waste management, chemical handling, and emergency response; familiarity with medical device manufacturing environments including clean rooms and sterile processing; ability to conduct risk assessments, job hazard analyses, and ergonomic…