Senior Project Manager

Responsibilities:

• Create and maintain remediation project schedules
• Identify resources needed and secure resource allocation, with leadership help, as needed
• Lead remediation team meetings, maintain risks and issues list(s)
• Recognize issues and develop solutions with the team to keep project(s) on track
• Support preparation for meetings with stakeholders to report status and present issues for decision-making
• Own the labeling remediation process
• Support the cross-functional content review of the clinical evaluation related deliverables

Qualifications:

• Experiences coordinating medical device projects working cross-functionally with contributing disciplines
• Understands key processes, including product development documentation, change control, labeling, clinical evaluation and post-market surveillance
• Able to organize across multiple initiatives and integrate work streams into a cohesive project
• Communicates effectively with team and stakeholders with appropriate levels of detail and escalates effectively, when needed

Education/Experience:

• Minimum of a completed Bachelors of Science focused in (discipline Engineering or Science discipline.)
• Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook
• Medical Device industry experience required
• Must have experience with multiple projects in parallel
• Previous remediation experience

Skills:

• Product Development (5 years of experience is preferred)
• Medical Device (5 years of experience is required)
• MDR (1 year of experience is preferred)
• Surgical Tools (1 year of experience is preferred)
• Project Lead (1 year of experience is preferred)