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, or vaccine‑device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of 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 be responsible for applying knowledge of product and process development in the (bio) pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead. The incumbent will interact extensively with subject‑matter experts on the DPPD team and members of internal cross‑functional product development teams from concept through product launch. The position will also ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements.

• Lead and set direction for the device development strategy for multiple drug‑device combination product programs from concept generation and selection, through development, verification, and validation to launch readiness.
• Lead cross‑functional Device Working Groups to ensure full integration of device development activities with clinical, regulatory, formulation, commercial, and other key company functions.
• Lead 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 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, including engineering design, engineering analysis and 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 the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under 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, relevant worldwide regulations and standards, and effectively share this knowledge with others.
• Enhance the company’s professional image through publications, presentations, patents, and professional activities.

• B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or another engineering discipline, plus 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 working knowledge of device, biologic/drug product, and process development, including regulatory submission and approval processes for drug‑device combination products or medical device components.
• 5+ years of leadership experience managing complex device or combination product development programs and leading cross‑disciplinary…