Director, Vision and Sensor Systems - 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.

About this Position: 

Calyxo is seeking a highly skilled and innovative engineering leader for our Vision and Sensor Systems Development Team, responsible for driving the design and development of advanced medical devices. The ideal candidate will oversee the development of hardware and firmware systems for endoscopic devices and capital equipment, ensuring optimal performance and integration. This individual will lead a multidisciplinary engineering team to support existing product lines while driving the development of next-generation technologies. The role also requires ensuring that all engineering efforts comply with industry standards and regulatory requirements, while aligning with strategic business objectives. 

In This Role, You Will: 

• Lead the Vision and Sensor Systems team by providing direction that clearly supports corporate goals and objectives; foster an environment of collaboration, growth, learning, and achieving at Calyxo.  
• Develop state-of-the-art vision and sensor hardware/firmware integrating technology into endoscopes and capital systems.  
• Work with cross-functional teams to define requirements for vision and sensor system performance.  
• Work with program management to define release content. 
• Organize design reviews to ensure coherent design across instruments and SW interfaces. 
• Review and approve change orders, test protocols/reports and design documents.  
• Coordinate team members and their activities to complete Design Verification testing and risk management activities.  
• Interact with suppliers and internal operations representatives to facilitate root cause investigation, component lifecycle management and continuous improvement.  
• Create technology roadmap for vision and sensors and manage research endeavors.  
• Foster a culture of continuous improvement and innovation among engineering and cross-functional teams.  
• Collaborate with cross-functional teams to bring prototypes to market.  
• Mentor and develop engineering talent, promoting a collaborative and high-performance work environment. 
• Hire top talent to meet business needs. 

Who You Will Report To: 

• Sr. VP of Research and Development

Requirements: 

• BS/MS in Mechanical, Optical, or Mechanical Engineering or a related technical field is required. Advanced degree desirable. 
• 12+ years of related experience in medical device product development.  
• A minimum of 5 years in a technical management role.  
• Deep technical expertise in multiple areas of engineering design for vision and sensor applications  
• Experience leading external vendors and contract manufacturers in the development of custom solutions  
• Exceptional problem-solving skills and experience leading multifunctional technical project teams through all development lifecycle phases 
• Experience in IEC60601 for medical devices or any other regulatory environment such as automotive or aerospace. 
• Experience in requirements definition, design reviews, change management and risk control  
• Excellent technical writing and verbal communication skills are a must. Presentation capabilities that can be tailored anywhere from team-level to C-Suite are essential.  
• Ability to work independently or in team setting required. 
• Must be self-directed, self-motivated and be able to multi-task in a fast-paced environment with multiple priorities.  
• Experience and involvement with MDRs, IDEs, and 510(k) filings is required.  
• Knowledge and ability to interpret and follow applicable regulations, guidelines, and policy statements is required. Must have experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. 
• Ability to travel domestically and internationally up to 10% of the time.  

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 base salary range of $230,000 - $277,000
• 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 

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. 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 required. In 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.