Senior Mechanical Engineer

2 weeks ago

Cambridge, United States CareerBuilder Full time

Position Title:

Senior Mechanical Engineer

Location:

Cambridge, MA

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) startup company translating scientific findings from MIT into therapeutic approaches for Alzheimers disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Cognito initiated our pivotal study for first-line treatment of Alzheimers in Dec 2022 and expects to start additional clinical studies in Mild Cognitive Impairment (MCI) and Parkinsons Disease in 2023. 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 with neurodegenerative conditions. With our patented gamma stimulation technology, we are committed to developing 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:

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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