Design Quality Engineer - Robot

Capstan Medical, Inc.•Santa Cruz, CA

6d•Onsite

About The Position

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.

Requirements

Bachelor's degree in Engineering or a related technical field.
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.

Nice To Haves

Master's degree is a plus.
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.

Responsibilities

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.