Senior Principal Device Technical Working Group Lead

Job Description

Our company’s Device Development and Technology (DD&T) 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 DD&T 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 parenteral delivery.  

Job description

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 the company’s highest complexity programs they are selected lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DD&T 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. 

This position will lead cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development, manufacturing process development, qualification and validation, design controls and device risk management techniques to positively support and influence clinical and commercial combination product development and launches.

Principal Responsibilities

• Lead and set direction for the device development strategy for multiple development programs ranging from concept generation/selection through commercialization and launch readiness:

  • Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.

  • 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 our Company functions.

  • Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, 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 select device technology platforms.

• Maintain a high level of engagement in all device development activities (e.g. 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)

• Maintain …