Design Quality Engineer - Robot

Capstan Medical Inc.; Santa Cruz (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, vision covered 100%

Flexible time off

Job summary

Capstan Medical Inc. in Santa Cruz, CA, is seeking a Design Quality Engineer to support design quality activities for our robotic platform. You will partner with R&D, regulatory and clinical teams to ensure safety, reliability, and manufacturability throughout development.

You will lead design control activities, develop and review FMEAs, support VERIFICATION and VALIDATION tests, participate in design reviews, and drive CAPA remediation while ensuring ISO 13485 and FDA 21 CFR 820.30 compliance.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years in a design quality assurance/engineering role in medical devices (electromechanical capital devices).
• Knowledge of design controls (21 CFR 820.30), ISO 14971, ISO 13485, IEC 60601-1, and related robotic medical device standards.
• Ability to manage multiple concurrent design control activities in a fast-paced startup environment.
• Strong documentation, organizational, and communication skills.

Responsibilities

• Support ISO 13485 and FDA 21 CFR 820.30 compliance throughout Product Development.
• Develop and maintain Design History File documentation and risk management artifacts (FMEA).
• Review and approve Design Verification and Validation protocols, methods, and reports.
• Participate in design reviews and provide feedback on controls and risk mitigation.
• Champion the quality system and drive continuous improvement and CAPA remediation.
• Assist in audits (internal and external) and respond to audit findings.
• Ensure regulatory compliance for robotic medical devices, including FDA QMSR and ISO 13485.

Skills

Design controls

ISO 13485

FDA 21 CFR 820.30

Risk management ISO 14971

CAPA management

Audit support

Design reviews

Documentation

Problem solving

Multitasking in startup

Education

Bachelor's degree in Engineering or related field

Master’s degree (a plus)

Tools

FMEA (Design/Use)

CAPA systems

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.
• Driven on conforming 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 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!

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.