Design Quality Engineer - Robot

Job Description

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

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.

• Support the 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 and maintain
  
  Design History File documentation and ensure compliancetointernal processes and external standards and regulations.

• Champion the 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.

• Bachelor's degree in Engineeringora related technical field.
  
  Master'sdegree is a plus.

• Minimum of 5 years of experience in adesignquality assurance/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 electrical equipment(IEC 60601-1), and other relevant quality & safety standards for robotic medical devices.

• Ability tosupport multiple concurrent design control activities in a fast-pacedstartupenvironment

• Strong documentation, organizational, and communication skills.

• 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.

• 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 you