Project Leader I

ACS Solutions

Job Description

Position: Project Leader-I - EU MDR remediation project

Work Location: Deerfield, IL / St. Paul, MN

Duration: 12 Months Contract

This Project Leader I 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
* 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

Interview platform: Video WebEx

Intake Notes:
* Medical Device industry (Surgical Tools, ideally) experience required
* PM from medical device background with the ability to work on multiple projects in parallel
* Previous MDR experience would be ideal
* Bachelors of Science focused in Engineering or Science discipline.
* Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook

Job Requirements

Position: Project Leader-I - EU MDR remediation project

Work Location: Deerfield, IL / St. Paul, MN

Duration: 12 Months Contract

This Project Leader I 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
• 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

Interview platform: Video WebEx

Intake Notes:
• Medical Device industry (Surgical Tools, ideally) experience required
• PM from medical device background with the ability to work on multiple projects in parallel
• Previous MDR experience would be ideal
• Bachelors of Science focused in Engineering or Science discipline.
• Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook

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