Senior Process Engineer

We are seeking a Senior Process Engineer with 10+ years of Medical Device experience to lead the development of innovative drug delivery devices , including auto-injectors, pen injectors, needle protection systems, fluid transfer devices, and micro-infusion pumps . The ideal candidate will provide technical leadership throughout the entire product development lifecycle, from concept and design through verification, validation, regulatory approval, and commercialization. Key Responsibilities Lead the development of innovative drug delivery devices from concept through commercialization. Provide technical leadership across the product development lifecycle, including design, verification, validation, regulatory approval, and manufacturing transfer. Lead Design Control activities and ensure compliance with applicable regulatory standards. Develop and execute process validation activities, including IQ/OQ/PQ. Perform risk assessments using FMEA and process optimization using DOE and SPC. Support verification & validation activities and prepare technical protocols and reports. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs. Ensure compliance with FDA, ISO, EU MDR, and other applicable medical device regulations. Support regulatory submissions including FDA 510(k), PMA, and CE Mark documentation. Required Qualifications Bachelor's or Master's degree in Engineering or a related technical discipline. 10+ years of electro-mechanical Medical Device product development experience. Strong experience with drug/device combination products and commercialization. Proven experience leading products through FDA 510(k), PMA, and CE Mark approvals. #J-18808-Ljbffr Shoolin Inc