EU MDR Project Manager

Automated Systems, Inc.

Job Description

Summary
The Project Manager will work under R&D leadership to lead the EU MDR remediation project(s) for the Advanced Surgery Global Business Unit product portfolio to support EU registrations through the relevant notified bodies for maintenance and MDR submissions.
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.
• Manage projects on a cross functional basis, including direct supervision of team members.
• Manage the project costs (all financial aspects) of product development. This will include capital expenditures and cross functional expenses.
• 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.
• Independent judgment in the evaluation, selection and adaptation of various engineering techniques required.
Location: Remote to Deerfield, IL or St. Paul, MN post COVID may be required to be in office a few days (hybrid model)

Requirements

Education / Experience:
• Minimum of a completed Bachelors of Science in the following disciplines: Mechanical, BioMedical, or Science.
• Minimum of open to 3-5 years of project management experience
• 5-8 years experience in device product development (sustaining or New Product Development).
• 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.
• Thorough, up to date knowledge of multiple disciplines required.
• Minimum of 3-5+ years of project management experience and with multiple projects in parallel

• Job Longevity

Job Requirements

  • Summarizing project status to project stakeholders
  • Manage project resources across multiple projects or project phases
  • Present project information to project team
  • Communicate project status to project team
  • Facilitating project status meetings and communicating project status to key project stakeholders
  • Resolve project issues and manage project risks
  • Manage project budget and project resource allocation
  • Manage project timelines using accepted project management methodology
  • Serve as project lead on projects with multiple project management staff
  • Meet project objectives while managing project hours
  • Validating project budget against estimated project costs
  • Manage project artifacts for the project
  • Prepare project plans, manage and track project execution activities for project teams
  • Achieve project objectives across the project portfolio
  • Monitor project execution/performance, project reporting and project resource allocations
  • Create project briefs and project schedules
  • Support defined project plans and project goals
  • Updating internal project management system
  • Complete project deliverables in accordance with project plan
  • Lead the project team to ensure project objectives

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