Director, Facilities & Environmental, Health & Safety - Pleasanton, CA

Calyxo • Pleasanton, CA

24d • Onsite

About The Position

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.

Requirements

• 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 cleanrooms and sterile processing; ability to conduct risk assessments, job hazard analyses, and ergonomic evaluations; experience supporting FDA, ISO 13485, and GMP compliance; ability to lead incident investigations and implement corrective and preventive actions; and understanding of industrial hygiene principles, exposure monitoring, and control strategies.
• Strong communication abilities; leadership presence; excellent problem ‑ solving and analytical thinking; high attention to detail; strong organizational skills; ability to follow instructions and manage multiple priorities; and a team ‑ oriented, continuous ‑ improvement mindset.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook); experience with EHS and facilities management systems such as incident tracking, CMMS, training platforms, and SDS databases; and the ability to interpret digital dashboards, metrics, and reporting tools.
• Legal authorization to work in the United States is required.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Nice To Haves

• Experience with pest control program for all facilities per quality procedures.
• Experience with waste streams common in urology device manufacturing (e.g., IPA, polymers, lubricants, sterilization residues, packaging materials).
• Experience managing hazardous waste vendors, manifests, and reporting.
• Experience leading sustainability initiatives focused on reducing waste from sterile packaging, plastics, and energy ‑ intensive processes.
• Experience developing and maintaining EHS policies, procedures, and training tailored to manufacturing of urology devices (catheters, scopes, disposables, electromechanical systems).
• Experience conducting risk assessments, job hazard analyses, and ergonomic evaluations for assembly, cleanroom operations, and equipment handling.
• Experience leading incident investigations and drive corrective/preventive actions.
• Experience overseeing industrial hygiene programs, including exposure monitoring for chemicals, adhesives, sterilants , and particulates.
• Experience managing emergency response programs, including spill response and medical emergencies.
• Experience ensuring facilities and EHS programs align with FDA, ISO 13485, and GMP requirements for sterile and non ‑ sterile urology products.
• Experience supporting safe handling of materials commonly used in urology device manufacturing (e.g., IPA, silicone, hydrophilic coatings, lubricants, adhesives, biocompatible polymers).
• Experience partnering with R&D and Quality to assess facility and EHS impacts of new product introductions, including device coatings, sterilization methods, and electromechanical components.
• Experience supporting audits and inspections from FDA, notified bodies, and customers.
• Experience contributing to risk management activities where EHS intersects with product safety, including ISO 14971 considerations.
• Experience serving as the site’s subject ‑ matter expert for facilities and EHS.
• Experience providing coaching and training to employees, supervisors, and cross ‑ functional teams; lead safety committees and drive a culture of accountability and continuous improvement.
• Experience developing and maintaining facilities and EHS metrics, dashboards, and reporting for leadership.
• Experience managing budgets, consultants, and external service providers.

Responsibilities

• 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 cleanrooms, 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 l ocal agencies, customers).
• Manage security, access control, janitorial, and site services.
• Manage pest control program for all facilities per quality procedures.
• 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.
• 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.
• 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.

Benefits

• Competitive salary offering a generous annual base range between $220,000 and $240,000 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 time off

What This Job Offers

• Job Type: Full-time
• Career Level: Director