Senior Project Manager, R&D - 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.

In This Role, You Will:

• Project Planning & Execution: Lead cross-functional teams through all phases of medical device development projects, including initiation, planning, execution, monitoring, and closing, ensuring timely delivery and alignment with business goals.
• Communication: Effectively communicate project status, project risks and major decisions. Escalate threats to commercialization projects as required to functional management and senior leadership.
• Resource Management: Predict resources needed to reach goals and manage resources in an effective and efficient manner.
• Risk Management: Identify potential project risks and develop mitigation strategies to ensure successful project delivery.
• Stakeholder Management: Collaborate with internal and external stakeholders, including marketing, R&D, regulatory affairs, manufacturing, and quality assurance teams, to align project objectives and drive results.
• Regulatory Compliance: Ensure all project activities comply with medical device regulations (e.g., FDA, ISO 13485, IEC 60601, IEC62304, CE Mark) and company quality systems.
• Design Control Documentation: Conduct regular design reviews, ensuring all design inputs and outputs are thoroughly documented and aligned with regulatory and quality standards.
• Vendor & Resource Management: Manage third-party vendors, contractors, or outsourced teams as necessary, and optimize resource allocation to maintain project efficiency and cost control.
• Product Lifecycle Management: Oversee the product development lifecycle, from concept, design, and prototyping to validation, verification, and production transfer.
• Quality Assurance & Testing: Collaborate with quality teams to define and execute software testing strategies, including unit testing, system integration testing, and validation according to regulatory standards.
• Continuous Improvement: Drive continuous improvement initiatives within the project management and product development processes, leveraging best practices and lessons learned. 

 Who You Will Report To:

•  Sr. Vice President of Research and Development

 Requirements:

• BS degree in Mechanical Engineering, Biomedical Engineering, or a related field. Master’s degress or PMP certification a plus. 
• Minimum 5 or more years of project management within medical device
• Deep understanding of medical device software regulations, including ISO 13485, IEC 62304, FDA 21 CFR Part 11 (for software validation), and cybersecurity best practices.
• Proficiency in software development tools, such as Git, Jira, Confluence, or other project management platforms.
• Experience managing cross-functional teams, including developers, testers, quality assurance, and regulatory professionals.
• Proven track record of managing complex product development projects, meet deadlines, and deliver high-quality products in a regulated environment.
• Experience with Agile development methodologies (Scrum, Kanban) and project management tools (e.g., MS Project, Jira).
• Strong analytical and problem-solving skills, with attention to detail and a focus on compliance and quality.
• Work location: Pleasanton, CA
• Travel: less than 10%
• Full time employment
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

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 range of $155,000 - $181,000
• 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.