Project Manager

Aditi Consulting is looking for a Project Manager to support cross-functional coordination for medical device and combination product development programs. The role involves creating and maintaining project plans, tracking progress, and ensuring alignment with quality and regulatory expectations.

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

Requirements:

• Ability to maintain integrated plans, schedules, milestones, action logs, risks, and status reporting
• Ability to work effectively across engineering, quality, regulatory, clinical, manufacturing, and supply chain teams in a matrixed environment
• Ability to manage multiple priorities, document decisions and actions accurately, identify issues early, and ensure commitments are completed