Product Quality Engineer - Robot

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands‑on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.

Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career-defining work.

Reports to:

Quality Manager

Workplace type:

Onsite in Santa Cruz, CA

The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line, supporting testing activities, and supporting packaging validation and finished goods release for robotic devices.

• Oversee product quality during all stages of productionandfield service.
• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process.
• Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering,identifying root causes, ensuringtimelyresolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
• Conduct Material Review Board and participate in materials decision making.
• Establish, implement, and support processes for field service and rework of robotic medical devices.
• Maintain Device History Records for robotic medical devices
• Support creation of risk management files, including the development of Process FMEA
• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes.
• Develop validation protocols, execute validation activities, and compile validation reports to ensure process robustness and consistency.
• Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.
• Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.
• Implement Lean and Six Sigma principles to drive continuous improvement initiatives.

• Collaborate with cross-functional teams to ensure that design, manufacturing, and standards-based test requirements are met.
• Provide guidance on processes and validations to ensure product safety and compliance.

• Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
• Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.

• Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
• Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.
• Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.

• Bachelor's degree in Engineering or related technical field. Master’s degree is a plus.
• Minimum of 5 years of experience in a manufacturing quality engineering role within the medical device industry supporting electromechanical capital devices.
• In-depth knowledge of FDA regulations, ISO 13485, IEC 60601-1, and other relevant quality & safety standards for robotic medical devices.
• Experience with nonconforming material investigations and…