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    Senior Mechanical Engineer - Cambridge, United States - Cognito Therapeutics, Inc.

    Cognito Therapeutics, Inc.
    Cognito Therapeutics, Inc. Cambridge, United States

    2 weeks ago

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    Description
    Position Title: Senior Mechanical Engineer

    Location: Cambridge, MA

    Company Description

    Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) company translating scientific findings from MIT into therapeutic approaches for Alzheimer's disease and other neurodegenerative conditions. We received FDA Breakthrough Device Designation based on our Phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Our device is in a pivotal study for first-line treatment of Alzheimer's, with potential expansion into Mild Cognitive Impairment (MCI) and Parkinson's Disease. We are a fast-moving, highly motivated team with a bold mission of bringing a novel therapy to the millions of patients in the world suffering from neurodegenerative diseases. With our patented gamma stimulation technology, we are committed to developing a pipeline of non-invasive device-based therapies.

    Summary of Role

    We are seeking a skilled Sr. Mechanical Engineer to contribute to the design, development, and manufacturing of our next-generation medical devices. As a key member of our engineering team, you will play a crucial role in bringing innovative solutions to market, ensuring product performance, reliability, and compliance with regulatory standards.

    Deliverables

    You will be responsible for:
    1. Product Design and Development:
    • Lead and contribute to the design and development of mechanical components and systems for medical devices.
    • Utilize CAD software to create detailed design drawings and specifications.
  • Prototyping and Testing:
    • Develop prototypes for proof of concept and testing purposes.
    • Conduct thorough testing and analysis to validate mechanical designs and ensure compliance with performance requirements.
  • Collaboration:
    • Work closely with cross-functional teams, including electrical engineering, software development, and regulatory affairs, to integrate mechanical systems seamlessly into the overall product architecture.
    • Mentor and provide technical guidance for interns and entry level engineers.
  • Regulatory Compliance:
    • Ensure all mechanical designs and components adhere to relevant industry standards and regulatory requirements.
    • Participate in the preparation of documentation for regulatory submissions.
  • Manufacturing Support:
    • Collaborate with manufacturing partners to optimize production processes and resolve any issues related to mechanical components.
    • Provide technical support during the transfer of designs to manufacturing.
    • Perform root cause analysis for clinical and commercial products.
  • Continuous Improvement:
    • Stay abreast of industry trends, emerging technologies, and best practices to incorporate into the design and development process.
    • Identify opportunities for innovation and efficiency improvements in mechanical design and manufacturing.
    Qualifications:
    • Bachelor's or Master's degree in Mechanical Engineering or a related field.
    • Proven experience in the design and development of mechanical systems for medical devices.
    • Proficiency in CAD software (e.g., SolidWorks, AutoCAD).
    • Strong knowledge of materials, manufacturing processes, and design for manufacturability.
    • Experience with design controls and risk management tools (FMEA)
    • Familiarity with regulatory requirements for medical devices (FDA, ISO, etc.).
    • Excellent communication and collaboration skills.
    • Ability to work in a fast-paced and dynamic start-up environment.
    • Experience with wearable technology is preferred.
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