Job Description

Project Manager

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

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