Senior Device Engineer

Get AI-powered advice on this job and more exclusive features. AesculaTech is more than a biotechnology company; it is a shared vision that cutting edge materials can personalize products and improve lives. We design environmentally responsive molecules to create best-in-class products that improve the safety and performance of outdated technologies. Our Device Development Team leverages these smart materials to create personalized medical devices, including our first-in-class treatment for dry eye disease. We have recently received IDE approval for our proprietary dry eye device and are set to begin pivotal trials, marking a major milestone toward commercialization. The Senior Device Engineer position provides multifunctional expertise and will help us commercialize a first-in-class treatment for dry eye disease. This role supports late-stage device development – including manufacturing, Verification & Validation (V&V) activities, US clinical study, and regulatory clearance. A successful candidate will be a capable problem-solver, skilled in manufacturing mechanical devices, and experienced working within a regulated environment with strong quality assurance practices. This is paid, 40 hr/wk, on-site position in Downtown Los Angeles, CA. Immediate responsibilities include managing manufacturing processes, supervising V&V testing, and maintaining quality assurance documentation. Conduct or manage R&D testing to confirm design or process changes. Support medical device Verification & Validation (V&V) by writing technical documents, executing testing, and managing service providers. Take a proactive role in managing relationships with CMOs producing our dry eye treatment device. Maintain comprehensive design control and QA documentation throughout the product development lifecycle. Assist in regulatory submissions and documentation to support product clearance. Support clinical trial operations and data integrity efforts. Work with internal teams, vendors, and external collaborators to address technical challenges. Present data and product updates to internal and external stakeholders. Contribute to the design, prototyping, and testing of the Gen 2 device platform, leveraging insights from the current product to improve performance, manufacturability, and scalability. Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering (or related field). 5+ years of experience in the medical device industry in R&D and/or manufacturing operations. Experience writing and executing technical protocols/reports. Proficiency in working within and maintaining a Quality Management System (QMS). Prior experience in managing V&V testing. Hands‑on skillset with workshop tools and measurement equipment. Strong project management and interpersonal skills to coordinate complex deliverables with vendors and external collaborators. Proficiency in MS Office and Google Workspace. Available to work on-site, 5 days per week. Desirable Qualifications Experience working in a start-up environment. Experience in manufacturing scale‑up and transfer. Experience supporting clinical trial operations. About AesculaTech AesculaTech was founded to bring revolutionary materials to the medical device industry. Imagine a product that can adapt to your body – taking its shape on contact and then hardening. Our team specializes in the design of molecules that make this possible. We chemically engineer intelligent materials that respond to their environment in a variety of ways. These smart materials are the first of their kind and offer next‑generation products in healthcare, consumer products, and beyond. An award‑winning startup, AesculaTech was named a Rosenman Innovator by the Rosenman Institute, the medical device arm of QB3, for their pioneering medical device development and participated in the accelerator programs Y Combinator and TMCx. The company was also the recipient of a National Science Foundation I‑Corps grant and a finalist in the 2019 Octane High Tech Awards. We are led by one of MIT Tech Review’s 35 Innovators Under 35. AesculaTech is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr