Product Development Engineer II

Role: Product Development Engineer II focused on designing and developing ENT (Ear, Nose, and Throat) medical devices. Primary objectives include translating concepts into reliable, high-quality devices while ensuring regulatory compliance. Responsibilities encompass device design, collaboration with vendors, development of prototypes and test tools, and conducting verification, validation, and pre-clinical studies. The role supports cross-functional teams throughout the product lifecycle, emphasizing manufacturability, testing, and regulatory standards. Requirements: Bachelor's in Engineering or equivalent, 3–5 years in medical device development, proficiency in CAD (SolidWorks), knowledge of design controls (ISO 13485, FDA QSR), risk management (ISO 14971), and statistical tools. Preferred qualifications include an advanced degree and experience with process mapping and project management tools. High-Value: ENT devices, Class I/II medical devices, on-site lab and office environment, up to 25% travel, working within fast-paced, regulated medical device development settings.