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.

• 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.

• 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.