Medical Device Engineering Lead (VP Level)

VP, Medical Device Engineering, Cognito Therapeutics, Inc.

Location: Cambridge, MA, Part-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) startup company translating scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed preservation of cognition and function in Alzheimer's patients. Cognito initiated our pivotal study for treatment of Alzheimer’s in Dec 2022, which is now at total enrollment. We are a fast-moving, highly motivated team of people with the ambitious goal of helping millions of patients and caregivers around the world who are burdened by neurodegenerative conditions. With our patented gamma stimulation technology, we are committed to developing non-invasive device-based therapies.

 

About the Job

Cognito Therapeutics, Inc., is seeking an experienced part-time Vice President of Medical Device Engineering to join our growing team in Boston and lead the development of our next-generation therapeutic platform for neurodegenerative diseases. This is a pivotal leadership role at the intersection of innovation, patient impact, and regulatory rigor—ideal for a hands-on engineering leader with deep experience in regulated medical device development and a passion for scaling breakthrough technologies.

 

As VP of Engineering, you’ll be responsible for translating our clinical and commercial vision into robust, scalable, and compliant hardware and systems. You’ll oversee a multidisciplinary team across mechanical, electrical, firmware, and systems engineering, while partnering closely with Product, Clinical, Regulatory, and Quality teams to deliver fully integrated solutions.

 

You’ll bring both strategic foresight and operational discipline to drive our roadmap through clinical trials, FDA submission, and into commercialization. This is a unique opportunity to help shape the future of neuroprotective therapy in a startup environment where your leadership will have an immediate and lasting impact on patient lives.

 

 

Roles and Responsibilities

 

Technical Oversight & Program Execution

• Lead cross-functional engineering efforts (systems, electrical, mechanical, and software) across development, V&V, and transfer to manufacturing.
• Translate strategic vision from the CTO into executable engineering plans that meet product, quality, regulatory, and business objectives.
• Oversee the integration of hardware and software components in compliance with FDA Class II medical device requirements.

• Ensure rigorous design control practices and technical documentation aligned with ISO 13485 and the FDA QMSR (21 CFR 820).

 

 Regulatory & Quality Alignment

• Collaborate closely with Regulatory Affairs, Clinical, and Quality teams to ensure engineering deliverables support Pre-Sub and De Novo/510(k) filings.
• Oversee technical inputs into Design and Development Files, Risk Management Files, and Verification & Validation testing strategies, into Design History Files (DHFs).
• Drive root cause investigations and lead resolution of hardware issues in collaboration with Quality and Operations.
• Support audit readiness and act as an engineering lead during internal and external audits.

 

Team Leadership & Development

• Manage and mentor a multidisciplinary team of engineers and technical consultants.
• Drive high performance through clear goal-setting, coaching, and technical upskilling aligned with product roadmap needs.
• Serve as a connector between hands-on technical contributors and executive leadership to ensure alignment and momentum.

 

Strategic & Cross-Functional Partnership

• Partner with Product, Clinical, Regulatory/Quality, Commercial, Market Access, and Manufacturing leaders to align engineering timelines with key business milestones (e.g., trial enrollment, FDA submissions, go-to-market).
• Provide engineering foresight during the transition from R&D into clinical manufacturing and commercial scaling. Work with other functions in engineering (e.g. software) to deliver fully integrated solutions.
• Lead all phases of hardware development from feasibility through commercial launch and lifecycle management.
• Contribute to portfolio planning and technology strategy in partnership with the CTO and senior leadership.

 

Operational Excellence

• Establish scalable engineering processes for requirements management, risk mitigation, and issue tracking.
• Drive decision-making around build-vs-buy, supplier selection, and design for manufacturability and reliability (DFM/DFR).
• Monitor engineering budget, resources, and timelines to ensure on-time, on-budget delivery of critical milestones.

 

Qualifications:

Required

• Bachelor's in Electrical, Mechanical, Biomedical Engineering, or a related field.
• 10+ years of engineering experience with 5+ years in a leadership role, including direct experience in regulated medical device development (Class II or III).
• Proven track record of delivering hardware-integrated systems from early-stage design through clinical use and successful regulatory submission.
• Deep familiarity with FDA QMSR (21 CFR 820), ISO 13485, IEC 60601,ISO 14971 and IEC 62304 and relevant standards for electromechanical devices.
• Demonstrated experience leading cross-functional teams in a start-up or fast-paced growth environment.
• Strong communication skills and comfort navigating between engineering detail and executive-level reporting.
• Ability to be onsite at least 50% time

 

Preferred

• Master’s or other Advanced Technical Degree
• Experience contributing to or leading technical content for FDA approved/cleared submissions.
• Knowledge of cybersecurity and software lifecycle standards
• Exposure to AI/ML-enabled devices or data-intensive platforms is a plus.
• Experience with medical device development at an early-stage startup