Project Manager

For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. 12-month contract Onsite in Newton, MA

Key Responsibilities: Plan and directly manage cross-functional projects, including coordination with external resources and contracted companies Develop comprehensive project plans in collaboration with program managers, senior leadership, and stakeholders Partner with development team members to ensure accountability for project tasks and deliverables Manage project budgets, prepare financial forecasts, and track actuals against projections Monitor project progress and implement corrective actions or contingency plans to meet key milestones and deliverables Required Qualifications: Bachelor’s degree in Engineering, Computer Science, or a related discipline 5–10 years of project management experience in medical device product development, from concept to commercialization Experience managing either: New product introduction or design transfer to manufacturing, or Verification and validation activities traced through needs and requirements Strong knowledge of FDA Quality System Regulation (21 CFR 820) and EU Medical Device Regulation Proficiency managing DHR (Device History Record) tracked deliverables such as incoming inspection, configuration management, and in-line inspection Demonstrated success in managing development changes prior to commercial release Willingness to travel up to 10%, as needed