Description
The Design Assurance Engineer supports on-market medical devices by applying design controls, facilitating design and manufacturing changes, maintaining regulatory compliance, improving manufacturability, and evaluating cost-reduction efforts. The role also supports health-risk assessments, audits, CAPAs, quality projects, risk management, product-change impact assessments, and post-market surveillance activities. A bachelor’s degree in life sciences, engineering, or a related discipline is required, while familiarity with FDA quality-system regulations, ISO 13485, the Medical Device Directive, and the EU Medical Device Regulation is desirable; Spanish and English are also desirable.
