Principal Scientist – Device Technical and Engineering Lead; Director Equivalent

Principal Scientist – Device Technical and Engineering Lead (Director Equivalent)

Our company’s Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine-device combination products to achieve safe and effective delivery to their intended site of action. The team manages the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration, including inhalation, implantation, and injection.

This position will apply expertise in product and process development within the (bio) pharmaceutical and/or medical device industries to set tactical and strategic direction for the programs they lead, ensuring high‑quality products and robust manufacturing processes. The role interacts extensively with subject‑matter experts on the DPPD team and members of internal cross‑functional product development teams from concept through product launch, ensuring compliance with regulatory, quality, company, and customer requirements.

This position will lead cross‑functional development teams within and external to Device Development & Technology, coordinating device development strategies and ensuring integration with clinical, regulatory, formulation, commercial, and other key company functions.

• Lead the cross‑functional Device Working Groups to ensure full integration of device development activities with other company functions.
• Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.
• Represent Device Development and the project‑specific Device Working Groups on cross‑functional teams, including the Development and Commercialization Team (DCT); maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).
• Serve as key point‑of‑contact with potential external device designers, developers, and suppliers for selected device technology platforms.
• Oversee and serve as a technical integrator of all device development activities: engineering design, analysis & testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis.
• Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within the Company and with external suppliers.
• Author and review relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• Lead/support clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.
• Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.
• Maintain a high level of engagement in the program‑specific design controls process and design history file development.
• Stay current with new device technologies, worldwide regulations, standards, and effectively share this knowledge with others.
• Enhance the company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.

• B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and Systems Engineering, or related field and a minimum of 10 years of combined experience in medical device and combination product development. Advanced degree preferred.
• 5+ years of leadership experience with deep knowledge of device, biologic/drug product, and process development, including regulatory submission and approval processes.
• 5+ years of leadership experience managing complex device or combination product development programs and leading cross‑disciplinary project teams.
• Broad knowledge of medical device development, design controls, risk management, device design, requirement management, design verification, automation/process…