Product Development Engineer

The Product Development Engineer will support the development and scale up of medical devices, drug delivery systems, and combination products. This role focuses on laboratory execution, experimental design, technical documentation, and collaboration across cross functional teams. The position plays a key role in design verification, validation, and commercial manufacturing readiness for innovative drug delivery technologies. Key Responsibilities Provide technical support for product development and laboratory scale up for medical devices and combination products Plan, design, execute, document, and analyze verification and validation testing activities Conduct design of experiments and functional testing to assess product performance and reliability Generate and summarize experimental data and prepare technical reports and slide presentations Support technology transfer, process development, optimization, and scale up activities Collaborate with cross functional teams including quality, regulatory, manufacturing, and supply chain Interface with contract manufacturing partners to ensure technical and operational alignment Assess risks, create test plans, analyze results, and document conclusions for compliance purposes Develop and review technical documentation including standard operating procedures and validation protocols Troubleshoot manufacturing challenges and support investigations related to deviations or process failures Required Qualifications Bachelor’s degree in biomedical engineering, mechanical engineering, chemical engineering, materials science, biotechnology, or a related field Experience in developing medical devices, drug delivery systems, or combination products Hands on laboratory experience in product design, development, testing, and characterization Knowledge of design verification, design validation, and usability applications Understanding of commercial scale manufacturing processes for pharmaceutical or medical device products Familiarity with regulatory and quality requirements including design controls and documentation Strong technical writing, data analysis, and presentation skills Excellent problem solving, communication, and collaboration abilities Preferred Qualifications Master’s degree or Doctorate in a relevant engineering or scientific discipline Experience with electromechanical pump devices, primary containers, or drug delivery platforms Knowledge of pre filled syringes, cartridges, auto injectors, eye care devices, or pumps Experience with technology transfer, process validation, and contract manufacturing organizations Familiarity with FDA and ISO standards and design history file documentation The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. #J-18808-Ljbffr