Design Quality Engineer, Surgical Robotics

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

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.