Design Quality Engineer — Surgical Robotics

Capstan Medical; Santa Cruz (CA); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Capstan Medical in Santa Cruz, CA is seeking a Design Quality Engineer to support design controls for our cardiovascular robotic platform. This onsite role partners with R&D, regulatory and clinical teams to ensure safety, reliability and manufacturability of our first-of-its-kind medical device.

You will drive ISO 13485, FDA 21 CFR 820.30 compliance, risk management, design verification and validation, and CAPA processes in a fast-paced startup environment.

Formación

• Bachelor's degree in Engineering or related field; master's preferred.
• 5+ years in design quality assurance for medical devices.
• Knowledge of 21 CFR 820.30, ISO 14971, ISO 13485, IEC 60601-1.
• Ability to manage multiple design controls in a startup.

Responsabilidades

• Support design control activities ensuring ISO 13485 and FDA 21 CFR 820.30 compliance.
• Develop risk management files, including Design FMEA and Use FMEA.
• Review and approve Design Verification and Validation protocols and reports.
• Participate in design reviews and maintain the Design History File.
• Drive CAPAs and nonconforming material investigations.

Conocimientos

Design quality assurance

Design controls (21 CFR 820.30)

Risk management (ISO 14971)

Quality management systems (ISO 13485)

Documentation & compliance

Educación

Bachelor's degree in Engineering

Master's degree in Engineering (preferred)

Descripción del empleo

Capstan Medical in Santa Cruz, CA is seeking a Design Quality Engineer to support design controls for our cardiovascular robotic platform. This onsite role partners with R&D, regulatory and clinical teams to ensure safety, reliability and manufacturability of our first-of-its-kind medical device.

You will drive ISO 13485, FDA 21 CFR 820.30 compliance, risk management, design verification and validation, and CAPA processes in a fast-paced startup environment.