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