Mechanical Engineer

Cognito Therapeutics; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Cognito Therapeutics, Inc. in Boston, MA, seeks a Mechanical Engineer to join our R&D team. You will design and implement wearable electro-mechanical systems from concept to production, defining requirements, prototyping, testing, and release.

You will work with systems, electrical, firmware, software, and mechanical engineers, own subsystems, perform design verification, and support manufacturing transfers in a regulated environment.

Qualifications

• BS in Mechanical Engineering with 5-8 years of experience in regulated industry.
• Experience owning mechanical subsystem development from concept to production.
• Hands-on integration of mechanical, electrical and firmware in wearables.
• CAD tools experience for design, tolerance analysis and system-level simulation.
• Familiarity with FDA QSR 21 CFR 820, ISO 13485, EU MDR and IEC 60601-1.

Responsibilities

• Lead design, architecture, integration, and verification of wearable subsystems and enclosures.
• Own mechanical component selection, design verification and system-level testing.
• Investigate field, manufacturing, and reliability issues via root cause analysis.
• Lead DFM/DFA and design transfer with Manufacturing Operations and CMMs.
• Provide schedule and budget input to support projects.
• Collaborate across systems, electrical, firmware, software and mechanical teams.
• Define and drive the mechanical architecture and technical direction.

Skills

Cross-functional collaboration

Verbal and written communication

System-level thinking

Prototype bring-up

Problem solving

Education

BS in Mechanical Engineering

MS in Mechanical Engineering

Tools

CAD software

Coordinate measuring machines (CMMs)

Mechanical prototyping tools

Job description

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 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 our therapy's strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer's.

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.

About the Job

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.

Roles and Responsibilities

• 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.

Qualifications

• BS in Mechanical Engineering, or related discipline, with 5-8 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.