Project Manager, Regulatory Compliance Specialist, Operations Management

Summary

You will serve as Project Manager and play a leadership role in maintaining our kidney stone treatment systems, accountable for leading multi‑disciplinary teams in operational and sustaining improvements. You will plan for long‑view work, balance day‑to‑day issues as they arise, define schedules, share information widely with team members and stakeholders, and foster healthy, productive teams. You will help us pursue ‘No stone left behind’!

• Communicate with clarity and impact
  :
  Provide visibility on project progress, decisions, dependencies, risks, and timelines to teams and senior staff. Ensure transparency through excellent written and verbal communication.
• Develop and drive cross‑functional alignment
  :
  Facilitate agreement among engineering, operations, supply chain, quality, commercial and regulatory on scope, priorities, and value delivery to achieve project objectives.
• Own execution
  :
  Lead planning and delivery of multiple, concurrent projects. Define objectives, success metrics, and guide internal and external contributors to execute effectively while adapting to changing conditions.
• Foster collaboration and trust
  :
  Build strong relationships across teams and levels to encourage knowledge sharing, accountability, and positive work habits.
• Enable technical delivery
  :
  Coordinate development activities. Manage prioritization, define “Done,” and lead planning and retrospectives for predictable delivery.
• Manage risks and remove obstacles
  :
  Anticipate challenges and eliminate barriers to progress. Apply structured risk‑based decision‑making, contingency planning, and trade‑off analysis to maintain momentum.
• Champion process improvement
  :
  Contribute to evolving project management practices and tools tailored to organizational culture, driving efficiency and scalability.
• Support portfolio planning
  :
  Partner with stakeholders to forecast future project delivery, update routinely, and balance resource capacity against active programs, ensuring successful execution across multiple initiatives.

• Sr. Professional Education Manager

• Education:
  
  BS Engineering/Science degree or equivalent required
• Minimum 5+ years total experience; medical device development experience strongly preferred
• Work location:
  
  Pleasanton, CA office
• Travel: ~10%
• Full‑time employment
• Hard
  
  Skills:
  
  experience with operational support of on‑market products, and development & cut‑in of improvements for hardware, firmware & capital systems. Familiarity with FDA submission process, QMSR requirements. Proficiency in MS Office, Atlassian/JIRA,  and other PM tools.
• Soft skills:
  
  strong facilitation and communication skills across technical and executive audiences. Ability to lead cross‑functional teams and influence without direct authority. Naturally accountable and organized.
• Physical requirements:
  
  Must be able to sit for up to 8 hours/day and operate standard office equipment.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

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.

• A competitive base salary $130,000 - $140,000 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 vacation

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.