Senior Principal Scientist - Device Technical and Engineering Lead; Senior Director Equivalent

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

Our company's Device – Product & Process – Development (D PP

D) Team designs, develops, and commercializes novel biologic/drug/vaccine – device enabled combination products to achieve safe and effective delivery to their intended site of action. The D PP D 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 their 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 to ensure high quality products and robust manufacturing processes. The position interacts extensively with subject‑matter experts on the D PP D team and members of internal cross‑functional product development teams from concept through product launch.

Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements.

Key responsibilities include:

• Lead and set direction for the device development strategy for multiple drug‑device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness.
• Lead the cross‑functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key 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, 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 our Company and with external suppliers.
• Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• Lead/support/oversee 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, standards, and effectively share this knowledge with others.
• Enhance our 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 other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development. Advanced degree is preferred.
• End‑to‑end leadership experience in a drug‑device combination product program from concept through clinical development, design transfer, regulatory submission, and commercial launch.
• Minimum 5+ years of…