Product Quality Engineer - Robot

Capstan Medical Inc.; Santa Cruz (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

Capstan Medical Inc. is seeking a Product Quality Engineer to provide quality engineering support for our manufacturing line, support testing activities, and assist in packaging validation and finished goods release for robotic devices.

The role requires a Bachelor’s in Engineering and at least 5 years in medical device quality engineering, with strong knowledge of FDA, ISO 13485, and GMP. Based onsite in Santa Cruz, CA, you will work with cross-functional teams to ensure product safety and

Qualifications

• Bachelor's degree in Engineering or related technical field; master's preferred.
• Minimum 5 years' experience in manufacturing quality engineering within the medical device industry.
• Deep knowledge of FDA regulations, ISO 13485, IEC 60601-1, and related quality & safety standards for robotic medical devices.
• Experience with nonconforming material investigations and implementing effective CAPAs.
• Ability to work in a fast-paced environment.

Responsibilities

• Oversee product quality during all stages of production and field service.
• Ensure GMP compliance and quality management systems throughout manufacturing.
• Lead investigations into nonconforming materials and products with cross-functional teams to identify root causes and implement CAPAs.
• Conduct Material Review Boards and participate in materials decision making.
• Establish and support processes for field service and rework of robotic medical devices.
• Maintain Device History Records for robotic devices.
• Support development of risk management files, including Process FMEA.
• Lead process validation activities (IQ/OQ/PQ) for new and existing manufacturing processes.
• Develop validation protocols and compile validation reports for robustness and consistency.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive process improvements.
• Perform audits of manufacturing processes to ensure adherence to quality standards.
• Implement Lean and Six Sigma to drive continuous improvement.

Skills

Quality engineering

GMP knowledge

Cross-functional

Education

Bachelor's degree in Engineering

Tools

QMS

Job description

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 Engineeris responsible forproviding 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:

• 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,identifyingroot 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.

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 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 implementing effective CAPAs.
• Ability to work in a fast-paced environment

Ways to stand out from the crowd:

• Experience supporting development and manufacturing of surgical robotic devices.
• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Familiarity with process validation (IQ/OQ/PQ), electrical safety testing, and packaging requirements for medical devices.
• Strong understanding of GMP regulations and quality management systems.
• Excellent problem-solving skills and ability to apply root cause analysis methodologies.
• Detail-oriented with effective organizational and documentation skills.
• Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.
• Attention to detail, with a focus on accuracy and precision in quality-related activities.

Why join us:

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiachealthcare space.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hardenvironment. Bring your bike or running shoesif you’d like or just be ready to enjoy a fun office outing.Weenjoytime inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.