Product Development Engineer

The Fountain Group is seeking a Product Development Engineer to support a leading client in North Chicago, IL . Details for the position below: Pay Rate: $40–$45/hr Contract Length: 12 Months (with potential to extend or convert based on performance and budget). Schedule: Monday–Friday, Onsite Job Summary We are seeking a Product Development Engineer to support the development of medical devices, drug-device delivery systems, and combination products. This role will focus on product and process development, laboratory testing, design verification and validation, experimental design, data analysis, and scale-up activities supporting commercial manufacturing. Key Responsibilities Provide technical support for the development and scale-up of medical devices, drug-device delivery systems, and combination products from laboratory studies through commercial manufacturing. Support product and process design, development, design verification, design validation, and usability activities. Plan, design, execute, document, and analyze testing used to evaluate, verify, and validate medical devices and combination products. Develop and execute Design of Experiments (DOE) and functional testing to evaluate product functionality, manufacturability, reliability, accuracy, sensitivity, and selectivity. Develop experimental protocols, test methods, and test plans based on product and process requirements. Support laboratory execution, data generation and collection, data analysis, results summaries, and technical presentations. Prepare technical reports, slide decks, study summaries, and other technical documentation. Establish methods for product investigations and evaluate testing programs for adequacy, sequence, and compliance with applicable requirements. Assess product and process risks and develop test plans based on identified risk priorities. Analyze test results, establish conclusions, evaluate residual risks, and assess whether test results adequately support conclusions. Support technology transfer, process development, optimization, process characterization, and scale-up activities. Work closely with Contract Manufacturing Organizations (CMOs) to ensure technical and operational alignment with company standards. Troubleshoot manufacturing challenges and support investigations into deviations, process failures, and other technical issues. Develop and review technical documentation, including SOPs, batch records, validation protocols, and technical reports . Required Qualifications Master's degree or PHD in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Materials Science/Engineering, Biotechnology, Pharmaceutical Engineering , preferred; 0–3 years of experience Experience developing medical devices, drug-device delivery systems, and/or combination products . Broad experience with product and process design, development, design verification, and design validation. Experience with product development and commercial-scale manufacturing . Strong understanding of electromechanical device development, laboratory testing, drug-device interactions, and system testing. Hands-on laboratory experience related to biomedical and mechanical design and development. Preferred Qualifications Experience with cGMP and regulatory requirements, including FDA and EMA expectations. Knowledge of ISO standards, design controls, Design History Files (DHF), and quality systems . Experience with technology transfer, process validation, process development, and process characterization. Experience working with Contract Manufacturing Organizations (CMOs) . Knowledge of analytical methods and pharmaceutical process development. Experience with human factors, usability studies, and patient-focused product development. PMP or project management experience. Experience with pre-filled syringes, cartridges, auto-injectors, eye-care delivery systems, eye droppers, aesthetic products, or pump-based drug delivery systems. Experience with pharmaceutical manufacturing processes involving small molecules and/or biological drug products. #J-18808-Ljbffr The Fountain Group