SECTION I · THE BRIEF
Brief #28276Updated 16 JUL 2026SANTA CRUZ, CALeverMEDICAL ORGANIZATIONS
Employbl Company Profile

Design Quality Engineer - Robot

Capstan Medical is creating minimally invasive technologies to treat heart valve disorders.

Location
Santa Cruz, CA
Company size
20–100
Posted
2mo ago
Via
Lever
Section II · Full ProfileFree with an account
  • 01Comp band & equity packageLocked
  • 02Seniority & experience requirementsLocked
  • 03Interview process & rubricLocked
  • 04Hiring manager & team contextLocked
  • 05Growth trajectory in this roleLocked
  • 06Offer & decision timelineLocked

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Design Quality Engineer - Robot

Capstan Medical· Santa Cruz, CaliforniaView company profile


Job title
Design Quality Engineer - Robot
Job location
Santa Cruz, California
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:
As a Design Quality Engineer, you will provide design quality support for the company’s design control activities, with a primary focus on the development of the surgical robot. You will partner with the R&D, regulatory, and clinical development engineering teams to ensure that our cardiovascular robotic platform is designed for safety, reliability, and manufacturability.
What you’ll do:
  • Support the execution of design control activities, ensuring compliance with ISO 13485 and FDA 21 CFR 820.30 throughout the Product Development Process.

  • Support creation of Risk Management Files, including the development of Design FMEA and Use FMEA.

  • Review and approve Design Verification and Validation protocols, test methods, and reports to ensure devices meet all functional, clinical, and standards-based requirements.

  • Participate in design reviews, providing critical feedback on design controls and risk mitigation.

  • Review and maintain Design History File documentation and ensure compliance to internal processes and external standards and regulations.

  • Champion the quality system and identify continuous improvement opportunities

  • Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings

  • Drive nonconforming material investigations and implementation of effective CAPAs

  • Ensure compliance with relevant regulatory requirements, such as FDA QMSR and ISO 13485 standards.

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 design quality assurance/engineering role within the medical device industry supporting electromechanical capital devices.

  • 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.

  • Ability to support multiple concurrent design control activities in a fast-paced startup environment

  • Strong documentation, organizational, and communication skills.

Ways to stand out from the crowd:
  • Experience supporting development of surgical robotic devices.

  • Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE).

  • Excellent problem-solving skills and ability to apply root cause analysis methodologies.

  • Detail-oriented with effective organizational and documentation skills.

Why join us:
  • We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare 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-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!

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Where this role is based

Santa Cruz, CA

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Capstan Medical headquarters

Santa Cruz, CA

Company size

20100 employees

Founded

2020

Total raised

$141,400,000

View company profile ↗