Design Assurance Engineer

Job Summary

Supporting new product development and post-market activities, the full-time Design Assurance Engineer will provide quality engineering support to cross-functional teams, ensuring compliance with design controls and regulatory requirements in a hybrid work environment.

Key responsibilities

• Collaborate with cross-functional teams to implement effective design controls throughout the product development lifecycle
• Conduct risk analysis studies using FMEA and other risk management tools to ensure product design compliance
• Review and approve design verification test plans, protocols, and reports while maintaining up-to-date knowledge of regulatory compliance requirements

Required qualifications

• Bachelor's degree or higher in a technical field such as Biomedical, Mechanical, or Electrical Engineering
• Experience with FDA regulations or ISO standards is preferred
• Ability to work independently and as part of a team, managing multiple priorities effectively
• Strong analytical skills and a flexible, positive attitude
• Good communication skills, comfortable presenting to others