Product Development Engineer II

Job Title: Product Development Engineer II Department: Design Engineering Reports to: Design Engineering Manager FLSA Exempt SUMMARY: The Product Development Engineer II is responsible for the technical execution of engineering activities supporting the development, modification, verification, commercialization, and lifecycle management of medical device products. This position applies engineering principles, analytical thinking, and structured problem-solving to evaluate product designs, investigate technical issues, formulate and document specifications, develop and execute verification activities, and ensure engineering deliverables are technically sound, accurate, and compliant with applicable Design Controls and Quality Management System requirements. The position works cross-functionally with Engineering, Manufacturing, Quality, Regulatory Affairs, and other functions to support product development and sustaining engineering activities. The Product Development Engineer II independently executes assigned engineering activities and work packages, exercising engineering judgment within established requirements and seeking guidance from senior engineering personnel for broader technical direction and complex design decisions. Essential Responsibilities: Execute engineering activities supporting new product development, product modifications, line extensions, and sustaining engineering in accordance with established project requirements and Design Controls. Apply engineering principles, analytical thinking, and structured problem-solving to evaluate product designs, materials, components, manufacturing processes, and product performance. Develop and evaluate design concepts and technical solutions within established product requirements and project objectives, and prepare product specifications, drawings, Bills of Material (BOMs), and other engineering documentation. Perform engineering analyses, including tolerance analysis, technical trade-off evaluations, failure analysis, and interpretation of product and test data. Develop and maintain Design History File (DHF) documentation, including design inputs and outputs, traceability, verification and validation documentation, and supporting technical evidence. Develop and execute design verification protocols and support design validation activities; analyze and interpret test data and prepare technically sound reports demonstrating compliance with applicable requirements. Participate in product risk management activities, including hazard analysis and FMEA, and provide engineering analysis to identify and evaluate appropriate risk controls. Participate in design reviews by providing technical analysis, test data, and recommendations and identifying potential technical risks or design deficiencies. Collaborate with Manufacturing Engineering and Operations to support Design for Manufacturability (DFM), prototype and pilot builds, process validation,…