Capstan Medical, Inc.
Design Quality Engineer - Robot
Santa Cruz, California
Sponsorship not specifiedDetected 6 days ago
Process ImprovementRoboticsFDA RegulatoryMedical DevicesCommunicationProblem Solving
About the role
- 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.
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.
- 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
- Ability to support multiple concurrent design control activities in a fast-paced startup environment
Requirements
- Experience supporting development of surgical robotic devices.
- Excellent problem-solving skills and ability to apply root cause analysis methodologies.
Nice to have
- Bachelor's degree in Engineering or a related technical field.
- Master's degree is a plus.
Benefits
- 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.
- Minimum of 5 years of experience in a design quality assurance/engineering role within the medical device industry supporting electromechanical capital devices.
Equal opportunity
- We are an equal opportunity employer.
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