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# Design Quality Engineer - Robot

- **Company:** Capstan Medical Inc.
- **Location:** Santa Cruz, CA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis
- **Published:** September 4, 2026
- **Apply:** https://startup.jobs/design-quality-engineer-robot-capstan-medical-inc-8763363

## About the Role

* 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.

## Description

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.


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