Principal Research Scientist II

Role: Device Technical Lead within Injection Device Development to provide technical leadership in device and combination product design, evaluation, and lifecycle management. Responsibilities: develop technical strategies, collaborate cross-functionally with operations, R&D, quality, regulatory, and manufacturing teams; oversee device design, risk management, verification and validation, and human factors; evaluate emerging technologies and regulatory trends; drive innovation and improve tools, methods, and performance; mentor technical staff and communicate concepts effectively. Requirements: Bachelor's degree in Mechanical Engineering or related field with 16+ years of experience; advanced degrees preferred; extensive experience in device or combination product development in regulated environments; expertise in design controls (e.g., 21 CFR 820, ISO 13485), risk management, verification/validation, and human factors; proven success in product launches or tech implementation; strong collaboration, communication, and decision-making skills; ability to translate technical strategy into actionable plans. High-Value: device development, combination products, regulated environment, design controls, risk management, product lifecycle, cross-functional collaboration, innovation in medical device technology. WorkSetup: not specified; likely hybrid or onsite based on typical device development environment.