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& EHSis responsible forstrategic leadership and oversight of all facilities operations maintenance programs and sitelevel environmental and safety compliance to ensure a safe reliable and auditready environment for the manufacturing of urologicalmedical rolerequires strong EHS experience and full ownership of site Environmental Health and Safety programs. This leader ensures a compliant and efficient environment supporting sterile and nonsterile manufacturing in a highly regulated setting.

In This Role You Will:

Facilities Leadership & Site Operations

• Oversee allfacilitiesoperations 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 (OSHAFDA ISO 13485 notified bodiesstate andlocal agenciescustomers).
• Manage security access control janitorial and site services.
• Manage pest control program for all facilitiesper 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.IPApolymers lubricants sterilization residues packaging materials).
• Manage hazardous waste vendors manifests and reporting.
• Lead sustainability initiatives focused on reducing waste from sterile packaging plastics and energyintensive 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 adhesivessterilants and particulates.
• Manage emergency response programs including spill response and medical emergencies.

Medical Device & UrologySpecific Responsibilities

• Ensure facilities and EHS programs align with FDA ISO 13485 and GMP requirements for sterile and nonsterile urology products.
• Support safe handling of materials commonly used in urology device manufacturing (e.g.IPAsilicone hydrophilic coatings lubricants adhesives biocompatible polymers).
• Partner with R&D and Quality to assess facility and EHSimpactsof 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 sites subjectmatter expert for facilities and EHS.
• Provide coaching and training to employees supervisors and crossfunctional teams; lead safety committees and drive a culture of accountability and continuous improvement.
• Develop andmaintainfacilities 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:Bachelors degree in Engineering Facilities Management Environmental Science Occupational Health & Safety or a related field;or equivalent relevant work experience.
• 10years 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 relatedlife 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 communicationabilities; leadership presence; excellent problemsolving and analytical thinking; high attention to detail; strong organizational skills; ability to follow instructions and manage multiple priorities; and a teamoriented continuousimprovement mindset.
• Proficiencywith 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.
• Physical requirements include the ability to lift up to 1025 pounds occasionally; stand walk or sit for extended periods (up to 8 hours/day); work in manufacturing and cleanroom environments while wearing required PPE; respond to emergencies including spill response and alarm situations; and work safely around chemicals equipment and other typical manufacturing hazards with appropriate protective equipment.
• Work location: Pleasanton CA (onsite)
• Travel: <5%
• Full time employment
• Compliance with relevant county state and Federal rulesregardingvaccinations.

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 a compensation plan as follows:

• Competitive salary offering a generous annual base range between $220000 and $240000 and variable incentive plan
• Stock optionsownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k) healthcare insurance and paid time off

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not onlyvalued but alsoprioritized. 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 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. If you receive a request for information from any other domain please contact us directly at 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.