Sr. Project Manager

Cognito Therapeutics, Inc. is a late clinical stage company focused on developing therapeutic approaches for brain health. The Sr. Project Manager will be responsible for driving complex cross-functional projects related to a wearable device for treating neurodegenerative diseases, ensuring timely execution and compliance with regulatory standards.

Responsibilities:

• Manages complex cross-functional design and development projects on a first in class wearable device for the treatment of Alzheimer’s disease and other neurodegenerative diseases
• Manages cross-functional projects to establish processes or process improvements
• Manage departmental projects, as requested
• Formulates and gains approval for project plans in consultation with program managers, and stakeholders; develops and sets milestones to ensure overall project success
• Works with cross-functional team (Engineering, Manufacturing Operations, Commerical, etc.) to ensure timely and complete deliverable execution (e.g., design control execution)
• Collaborates with Quality and Regulatory to ensure the project is fully compliant with the Quality System, FDA design controls, and global regulatory agency requirements
• Partners with development team members to drive accountability of project tasks and deliverables
• Develop and manage project plan and manages project budgets, generates forecasts, and tracks actuals against forecasts
• Identifies, analyzes, and tracks project risks and issues and monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments
• Conducts “Lessons Learned” reviews as needed

Requirements:

• BS in engineering or technical field, or equivalent practical experience
• 7+ years of experience leading and executing the coordination of projects in the medical device or pharmaceutical industry (at least 3+ years in medical device), resulting in the delivery of products
• Experience with medical device development and design control is required
• Product development experience from concept development through commercialization
• Demonstrated understanding of FDA Quality System Regulation (21 CFR 820), ISO 13485, and EU Medical Device Regulation
• Excellent communication and project management skills with a track record of successfully delivering projects on time
• Experience meeting multiple project schedules on time
• Strong verbal and written communication, analytical and problem solving, negotiation, and interpersonal skills
• Proficiency with project management and budgeting tools
• Experience working with products and processes incorporating hardware, firmware, and software