Design Assurance Engineer

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