Design Assurance Engineer II

Apply structured, data‑driven problem‑solving methodologies to identify, communicate, and resolve quality issues. Develop, update, and maintain Design History Files (DHF), including Design Inputs, Outputs, and product specifications. Evaluate, develop, and validate test and inspection methods to ensure robust design performance. Support regulatory submissions and interactions with notified bodies. Minimum of a Bachelor's degree in Engineering or a related technical discipline Minimum of 2 years of experience in Design Assurance, Quality, R&D, or New Product Development within medical devices or another regulated industry Strong analytical and problem‑solving skills, with the ability to guide teams through structured investigations Ability to work effectively in a matrixed, geographically diverse organization Hands‑on experience using quality tools and methodologies Working knowledge of FDA regulations, GMP, and ISO 13485 Advanced computer skills, including statistical analysis, data interpretation, and technical reporting Project leadership experience, with the ability to influence cross‑functional teams and drive timely, high‑quality outcomes Effective collaborator who thrives in both team‑based and self‑directed environments Clear, confident communicator (written and verbal)