Sr. Project Manager

This is a rare opportunity to join a team that is bringing an entirely new category of brain health to the world. At Cognito, we are developing therapies designed to promote dignity, clarity, and coherence in the lives they touch. Cognito is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, designed to work with the brain's own activity and biology. Born from pioneering neuroscience research at MIT, Cognito brings together neuroscience, engineering, medicine and technology to translate breakthroughs in brain science into practical therapies designed for everyday life. Our first therapeutic application, Spectris AD, is an investigational, prescription, at-home therapy for Alzheimer's disease. With our pivotal HOPE study now complete, Cognito is entering an important new phase as we advance Spectris AD toward regulatory review, prepare for potential commercialization and continue exploring the broader potential of our science across neurological health. We are building an interdisciplinary team united by a shared purpose: protecting and progressing the human ability to think, learn and remember. For innovators who want to work at the intersection of breakthrough science, technology and human health, Cognito offers the chance to help shape what comes next. About the Job Cognito Therapeutics, Inc., is seeking an experienced Sr Project Manager to join our growing Program Management team tasked with driving projects and programs forward. In collaboration with the Program Management team, this individual will be responsible for project definition, , planning, timelines, and facilitating execution to timelines across all areas of the company. This individual will work together with the cross-functional project teams to identify project risks, set milestones, and ensure project completion on time and within budget by maintaining focus on the critical path. They will be responsible for reviewing and reporting the status of the project with the team and to the Program Management team. We are looking to add a versatile, collaborative, and driven individual to our team. Key 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, Commercial, 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. Qualifications Required - BS in engineering or technical field, or equivalent practical experience - 8+ 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. - Experience working with products and processes incorporating hardware, firmware, and software is preferred. - Proficiency with project management and budgeting tools. - Travel required as needed. Competitive Benefits Cognito Therapeutics offers a comprehensive benefits package to employees working 30+ hours per week, starting on the date of hire: medical, dental, and vision insurance; virtual medical support; a Health Savings Account and Flexible Spending Accounts; company-paid life and AD&D, short-term disability, and long-term disability insurance; a 401(k) plan with Roth option; tuition reimbursement; an employee assistance program; pre-tax commuter benefits; and voluntary benefits such as supplemental life, accident, critical illness, hospital indemnity, legal, identity theft, and pet insurance. Unlimited paid time off includes flexible (non-accrual) vacation, 12 paid holidays, 80 hours of paid sick leave each year, and up to 12 weeks of fully paid parental leave, plus any additional paid leave required by state or local law. Physical Requirements & Work Environment • This role is primarily performed in an office or home-office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in-person meetings. • Occasional travel to partner sites may be required. For remote roles, occasional travel to Cognito’s Cambridge, MA office may also be required. Cognito Therapeutics is committed to providing reasonable accommodation for qualified individuals with disabilities throughout the application and hiring process. If you require accommodation, please contact us at recruitingteam@cognitotx.com. Cognito Therapeutics is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and make employment decisions based on qualifications, merit, business needs, and job requirements. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law. All applicants must be legally authorized to work in the United States.