The Project Manager, **Combination Products** Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.). The Project Manager ensures that the **strategy and plans** defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and **Product Strategy** teams. In addition, **product development** timing and scope need to support plans for CMC gate reviews and each clinical phase. **Summary of Responsibilities and Accountabilities:** The Project Manager will be accountable to the Program Manager Director for delivering on the **strategy, plans** and budget defined for the project portfolio. **Responsibilities include:** ¬タᄁ Leadership of a **portfolio of drug delivery** system product development projects ¬タᄁ Tactical and **strategic management** of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners ¬タᄁ **Device financial management** including budgeting, forecasting and long-range planning of delivery development expenses ¬タᄁ Representing the R&D organization to cross functional leadership through effective and timely communication ¬タᄁ Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions **Qualifications** ¬タᄁ Required: **Bachelor¬タルs Degree in Engineering** or related technical field ¬タᄁ Certification: **Project Management Professional (PMP)** Certification preferred, but not required ¬タᄁ **8+ years of experience in the combination product** or medical device industry with proven experience in developing medical devices or **combination products;** broad experience in **design controls, human factors studies, design verification/validation** and usability studies. ¬タᄁ Leadership of technical professionals; proven effective leader to cross-functional teams ¬タᄁ Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems. ¬タᄁ Requires an in-depth understanding of the pharmaceutical and device **product development cycle.** ¬タᄁ **Design history file** , project management and product development experience is essential. ¬タᄁ Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.