Project Manager

Overview Plans and directly manages cross-functional projects that may include external resources and contracted companies Formulates and gains approval for overall project plans in consultation with program managers, senior management and stakeholders Partners with development team members to drive accountability of project tasks and deliverables Manages program budgets, generates forecasts, and tracks actuals against forecasts Monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments Required skills to have for the success of this role B.S. in Engineering, Computer Science or related discipline 5-10 years of project management experience in medical device product development - from concept development through commercialization. Preferred experience in either: Managing new product introduction, or transfer of design to manufacturing. Managing verification and validation activities traced through needs and requirements Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and EU Medical Device Regulation Project Management Professional (PMP) certification preferred Experience managing DHR tracked deliverables preferred, including incoming inspection, configuration management & in line inspection, especially with development change control prior to commercial release. ~10% Travel (possible)