Design 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:
What you’ll do:
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Support the execution of design control activities, ensuring compliance with ISO 13485 and FDA 21 CFR 820.30 throughout the Product Development Process.
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Support creation of Risk Management Files, including the development of Design FMEA and Use FMEA.
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Review and approve Design Verification and Validation protocols, test methods, and reports to ensure devices meet all functional, clinical, and standards-based requirements.
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Participate in design reviews, providing critical feedback on design controls and risk mitigation.
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Review and maintain Design History File documentation and ensure compliance to internal processes and external standards and regulations.
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Champion the quality system and identify continuous improvement opportunities
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Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings
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Drive nonconforming material investigations and implementation of effective CAPAs
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Ensure compliance with relevant regulatory requirements, such as FDA QMSR and ISO 13485 standards.
What you’ll need:
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Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.
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Minimum of 5 years of experience in a design quality assurance/engineering role within the medical device industry supporting electromechanical capital devices.
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In-depth knowledge of design controls (21 CFR 820.30), risk management (ISO 14971), quality management systems (ISO 13485), basic safety and essential performance of medical electrical equipment (IEC 60601-1), and other relevant quality & safety standards for robotic medical devices.
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Ability to support multiple concurrent design control activities in a fast-paced startup environment
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Strong documentation, organizational, and communication skills.
Ways to stand out from the crowd:
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Experience supporting development of surgical robotic devices.
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Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE).
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Excellent problem-solving skills and ability to apply root cause analysis methodologies.
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Detail-oriented with effective organizational and documentation skills.
Why join us:
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We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
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We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
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We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!