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

Overview

Senior Principal Scientist – Device Technical and Engineering Lead (Sr. Director Equivalent). The Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine–device enabled combination products to achieve safe and effective delivery to their site of action. The DPPD Team manages the development of the device constituent across a pipeline of combination products for various therapy areas and routes of administration including inhalation, implantation, and injection.

This position applies knowledge of product and process development in the (bio) pharmaceutical and/or medical device industries to set tactical and strategic direction on programs to ensure high quality products and robust manufacturing processes. The role interacts with subject-matter experts on the DPPD team and cross-functional product development teams from concept through product launch and ensures compliance with applicable regulatory, quality, company, and customer requirements.

This position leads cross-functional development teams within and external to Device Development & Technology.

The incumbent must work well with all levels of employees and coordinate the execution of device development strategies. The role applies knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management to support and influence clinical and commercial combination product development and launches.

• Lead and set direction for the device development strategy for multiple drug–device combination product programs from concept generation/selection, 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 functions.
• Lead the Device Development Engineering Core teams focused on developing design requirements for the combination product and engineering execution against established requirements.
• Represent Device Development on cross-functional teams, including the Development and Commercialization Team (DCT), and 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 act as a technical integrator of device development activities including engineering design, 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 communicate complex technical challenges, 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 leadership.
• Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent.
• Support development, implementation, and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.
• Maintain a high level of engagement in the design controls process and design history file development.
• Stay current with new device technologies and worldwide regulations, and share knowledge with others.
• Support publications, presentations, patents, and professional activities to enhance the company’s professional image and competitive advantage.

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or related engineering field, plus a minimum of 15 years of combined experience in medical device and/or 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,…