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:

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:

• Supportthe execution of design control activities, ensuring compliance withISO 13485 and FDA 21 CFR 820.30 throughout the Product Development Process.

• Supportcreation ofRisk Management Files, including the development ofDesignFMEA and UseFMEA.

• Review and approve Design Verification and Validation protocols, test methods,and reports to ensuredevicesmeet all functional,clinical, and standards-basedrequirements.

• Participate indesign reviews, providing critical feedback on designcontrolsand risk mitigation.

• Review andmaintainDesign History File documentationand ensure compliancetointernal processes and external standards andregulations.

• Championthe quality system andidentifycontinuous improvement opportunities

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

• Drivenonconforming materialinvestigationsand 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 Engineeringora relatedtechnical field.Master'sdegree is a plus.

• Minimum of 5 years of experience in adesignqualityassurance/engineering role within the medical device industry supporting electromechanical capital devices.

• In-depth knowledge ofdesign controls (21 CFR 820.30), risk management(ISO 14971), quality management systems (ISO 13485),basic safety and essential performance ofmedical electricalequipment(IEC 60601-1), and other relevant quality & safety standards for robotic medical devices.

• Ability tosupport multiple concurrent design control activitiesin a fast-pacedstartupenvironment

• Strongdocumentation, organizational, and communication skills.

Ways to stand out from the crowd:

• Experiencesupportingdevelopmentof surgical roboticdevices.

• 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 ontransformationaltechnologiesin thecardiachealthcare space.

• We offer outstanding benefits with medical, dental,and vision covered at 100% for you and your family, as well as flex time off.

• Wethrive in ourwork-hard, play-hardenvironment. Bring your bike or running shoesifyou’dlike orjust 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.