Mechanical Engineer

Mechanical Engineer Cognito Therapeutics Inc. Location: Boston MA USA Full-time (Hybrid)

Company Description

Cognito Therapeutics Inc. is a venture-backed (Morningside Ventures FoundersX IAG Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health including Alzheimers disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapys strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimers.

We completed enrollment in our pivotal study HOPE in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology we are committed to developing convenient safe and effective neuroprotective therapies to improve brain health and well-being for all.

Cognito Therapeutics Inc. is seeking a detail-oriented Mechanical Engineer to join our growing R&D team tasked with supporting the design and implementation of complex wearable electro-mechanical systems from concept to production. Responsible for specification testing and documentation of mechanical subsystems from system to component level. Must work within project timelines to develop system requirements prototype test debug and release designs to production.

• Lead the design architecture integration and verification of complex wearable electro-mechanical subsystems and enclosures.
• Own mechanical component selection design verification and system-level integration testing including prototype bring-up.
• Investigate and resolve field manufacturing and reliability issues through root cause analysis and corrective action.
• Lead DFM/DFA and design transfer activities in partnership with Manufacturing Operations and contract manufacturers.
• Provide schedule and budget input to support project management.
• Work closely with systems electrical firmware software and mechanical engineers on new designs and design changes.
• Define and drive the mechanical architecture and technical direction for new product development.

• BS in Mechanical Engineering or related discipline with 58 years of experience (or MS with equivalent experience) developing complex hardware products in a highly regulated industry is required.
• Demonstrated experience independently owning mechanical subsystem development from concept through production release including prototype development verification design transfer and manufacturing support is required.
• Hands-on experience integrating mechanical electrical and firmware subsystems in a wearable or portable electronic product is required.
• Experience with CAD tools for mechanical design tolerance analysis and system-level simulation is preferred.
• Experience with wearables portable battery-operated products and mechanical packaging/enclosure design is preferred.
• Familiarity with FDA Quality System Regulation (21 CFR 820) ISO 13485 EU MDR and IEC 60601-1 or similar compliance standards is preferred.
• Experience integrating sensors displays audio and optics into mechanical enclosures is a plus.
• Expertise working with mechanical test and measurement equipment including coordinate measuring machines (CMMs) force/torque gauges and environmental test chambers.
• Strong verbal and written communication skills with the ability to work effectively across cross-functional engineering teams.