Design Quality Engineer - Robot

Job description

Job 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

Job requirements

• 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…
• Ability to support multiple concurrent design control activities in a fast-paced startup environment
• Strong documentation, organizational, and communication skills.