Senior Product Development Engineer I

Role: Senior Product Development Engineer I leading the full lifecycle development of ENT medical devices, from concept to market. Responsibilities: design and develop ENT devices and accessories, collaborate with vendors, create prototypes and develop test protocols, perform verification, validation, and usability studies; incorporate VOC inputs; lead technical reviews; ensure regulatory and quality compliance; communicate project status and risks. Requirements: Bachelor’s in engineering, 4+ years in medical device development, proficiency in CAD (SolidWorks), strong project management, problem-solving skills, and experience with design controls, risk management (ISO 14971), and relevant standards (ISO 13485, FDA QSR). Preferred: Mechanical Engineering degree, knowledge of statistical analysis (Minitab), process mapping (Visio). High-Value: Medical device sector, ENT specialty, regulated environment, design for manufacturability, cross-functional collaboration. Work setup: Office, remote, or hybrid; travel up to 25%.