Manufacturing Engineer
1 day ago
Manufacturing Engineer, Cognito Therapeutics, Inc.
Location: Cambridge, MA, USA, Full-time
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
We are seeking a highly motivated and experienced Manufacturing Engineer to join our Manufacturing team and work closely with Contract Manufacturers and internal teams—including mechanical design, quality, supply chain, and manufacturing.
Roles and Responsibilities
Provides support to the Contract Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met.
- Develop early-stage assembly processes.
- Create draft process work instructions
- Troubleshoot current design and process challenges, determine root cause, and implement robust solutions.
- Support the Improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities of manufacturing.
- Implement process documentation changes.
- Support Process Validation (IQ/OQ/PQ)
- Knowledgeable in the creation of validation, pFMEA and other operations support documentation.
- Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality.
- Collaborate with contract manufacturing sites to improve product quality and achieve company goals.
- Assist in maintaining systems for regulatory compliance.
- Work with cross-functional groups including Product Development and Quality Engineering to analyze and disposition non-conforming products.
- Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing.
Qualifications
- Strong communication and interpersonal skills.
- Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering. Preferably BSEE
- Minimum of 3-5 years' experience in medical device manufacturing
- Proficiency with Microsoft Office applications and Solidworks
- Ability to interact with client companies (customer focused) and co-workers in a professional manner.
- Willingness to support other functions as needed, in areas such as quality and design.
- Willingness to travel to vendors and customer sites as needed (up to 25% travel, Predominately Rhode Island site)
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