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 Opportunity: 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. ### What you’ll do: Manufacturing responsibilities include: - Oversee product quality during all stages of production and field 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, ensuring timely resolution, 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. Testing responsibilities include: - 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. Packaging and Finished Goods Release responsibilities include: - 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. Documentation and Compliance responsibilities include: - 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. ### What you’ll need: - Bachelor's degree in Engineering or a related technical field. Master's degree is a plus. - Minimum of 5 years of experience in a manufacturin…