Associate Principal Engineer, Drug-Device Combination Products

Role: Hands-on medical device manufacturing and assembly engineer within the Device Development & Technology group, focusing on combination products like autoinjectors, inhalers, implants, and infusion devices. Objectives include developing and qualifying assembly processes and equipment for clinical and commercial use, ensuring device performance, quality, and compliance. Responsibilities encompass leading technical teams, designing and authoring process FMEAs, validation protocols (IQ, OQ, PPQ), managing equipment suppliers, troubleshooting assembly systems (vision, ultrasonic welding, automated feeding), and supporting technology transfer. Qualifications: B.S. in Mechanical Engineering or related field with at least 15 years of regulated industry experience, expertise in automated device assembly, process validation, and supplier management. Skills include design controls, risk assessment, manufacturing strategies, and hands-on troubleshooting; CAD knowledge (SolidWorks) and prototyping skills are preferred. High-value biopharma specifics: emphasis on combination product assembly, supporting both clinical and commercial manufacturing, with a focus on device quality attributes and process robustness. Work setup: hybrid, with 10% travel.