Project Coordinator- Medical devices Job

Project Coordinator- Medical devices
Location: Minneapolis, MN USA
Onsite Position

Job Summary:
We are seeking a detail-oriented Project Coordinator to support Sustenance project execution through effective coordination, process mapping, and cross-functional collaboration. This role will work closely with project managers and functional teams to ensure smooth communication, well defined processes, and timely project delivery.

Key Responsibilities:
• Conduct process mapping exercises to document, analyze, and improve project and operational workflows.
• Support project management activities, including scheduling, tracking deliverables, and maintaining project documentation.
• Manage labeling activities, ensuring alignment with project schedules, quality standards, and regulatory requirements.
• Coordinate closely with cross functional teams, including packaging, regulatory, quality, and operations, to ensure timely and accurate labeling execution.
• Manage labeling schedules, workflows, and change requests to support production and project timelines.
• Change Order Management using PLM tools such as Agile, Windchill or similar tool.
• Manage stakeholder communications by organizing meetings, preparing updates, and ensuring timely dissemination of information.
• Assist in identifying dependencies, risks, and issues, and escalate them appropriately to project leadership.
• Ensure adherence to established processes, standards, and project governance requirements.

Required Qualifications:
• Bachelor’s degree in Engineering, Life Sciences, Packaging, or a related discipline
• Proven experience in process mapping and documentation.
• Strong coordination, organizational, and time management skills.
• Demonstrated ability to work effectively in cross functional team environments.
• Excellent verbal and written communication skills.

Preferred Skills:
• Knowledge about Medical device QMS such as ISO 13485 or 21 CFR 820.
• Understanding about Labeling systems and tools such as Loft ware, P360, AI etc.
• Familiarity with medical device labelling regulations such as ISO 15223-1 and ISO 20417.
• Familiarity with process mapping tools and methodologies.
• Experience supporting project management activities in structured or regulated environments.
• Strong attention to detail and problem solving abilities.
• Ability to manage multiple tasks and priorities concurrently.
• Proficiency in standard office tools such as MS Excel, PowerPoint, and collaboration platforms.