Project Manager

Woburn, MA, US
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The Project Manager will help create and drive project schedules for the cross-functional product development team. This team is developing medical devices under a Quality Management System compliant with FDA 21 CFR 820 and ISO 13485 standards. This individual will work closely with R&D engineers, Quality, Regulatory, Clinical, and Manufacturing representatives. The Project Manager will create detailed schedules when needed, facilitate discussions to drive problem-solving, and help the team meet its timelines for design, development, verification, and validation activities. This role is based out of the Woburn, MA office.
Essential Duties and Responsibilities:
  • Develop, establish, and maintain detailed project schedules
  • Work closely with project team members to clearly communicate deliverables and understand progress toward these deliverables
  • Highlight areas of project risk and facilitate discussions to keep the project on schedule
  • Help create and update project documents when needed to ensure compliance with design controls
  • Assist in coordinating key project activities
  • Facilitate design reviews and document reviews
  • Facilitate weekly project meetings, create meeting minutes, and track key action items
  • Develop and maintain dashboards of milestones and other key project metrics for each project
  • Review project documents for accuracy, completeness, and consistency
  • Facilitate document routing and approval process using PLM system
  • Drive process improvements and best practices related to Design Control, Change Control, and Project Management
  • Other duties as assigned.

Education and/or Experience:
  • Bachelor’s Degree
  • At least 5 years of project management experience required in medical device industry
  • Working knowledge, understanding and experience working within a Quality Management System compliant with 21 CFR 820, ISO 13485:2016, and ISO 14971 processes
  • Expertise with design control, verification, and validation
  • Proficiency with Microsoft Office suite; familiarity with quality systems desired
  • Proficiency in Project Management software such as Microsoft Project or Smartsheet
  • Be driven, energetic, with high personal integrity
  • Possess effective written and verbal communication, presentation, facilitation, and project management skills
  • Able to manage multiple priorities and execute on time 
  • Possess effective leadership skills; able to lead, motivate and inspire others

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