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:
Education and/or Experience:
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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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