Description

Responsibilities:

• Support cross-functional coordination for medical device and combination product development programs from development through commercialization.
• Assist in the creation and maintenance of integrated project plans, timelines, milestone trackers, and action logs.
• Partner with team members across engineering, quality, regulatory, clinical, manufacturing, supply chain, and other functions to support aligned execution.
• Help coordinate core team meetings and program reviews by preparing agendas, capturing decisions, documenting action items, and following up on commitments.
• Track project progress against timelines and milestones and escalate risks, delays, or cross-functional issues as appropriate.
• Support preparation of project dashboards, status reports, presentations, and milestone review materials for team and leadership meetings.
• Help maintain program documentation and support readiness for design reviews, phase gates, verification, validation, design transfer, and launch activities.
• Assist with risk, issue, assumption, and change tracking to support program visibility and execution.
• Support coordination of selected activities with external partners, suppliers, and contract manufacturers, as applicable.
• Contribute to process improvement efforts related to project management tools, team routines, templates, and reporting practices.
• Help ensure project activities remain aligned with applicable quality system, design control, and regulatory expectations with guidance from functional experts

Key Skills

Education

Bachelor's or Master's degrees