Senior Manufacturing Engineer

Job TitleSenior Manufacturing EngineerLocationLos Angeles, CA (On-site)Company OverviewAneuvo is a bioelectronic medical device company developing advanced neuromodulation technologies to treat conditions and injuries that have been resistant to traditional medical approaches. Founded in 2016 by UCLA researchers Dr. Wentai Liu and Dr. Yi-Kai Lo, the company's mission is to restore functional independence and improve quality of life for people with disabling diseases and spinal cord injuries. Its flagship product, the ExaStim Stimulation System, is a non-invasive, portable spinal neuromodulation device designed to help improve or restore motor function and strength. ExaStim has received both FDA clearance in the U.S. and CE Mark approval in Europe, marking significant milestones in Aneuvo's effort to make safe, home-based neurorehabilitation accessible worldwide The Senior Manufacturing Engineer - New Product Development & Sustaining Products is responsible for developing, validating, and sustaining manufacturing processes for new and commercialized medical devices. This role focuses on manufacturing process development, design transfer, production scale-up, and post-market process improvements while ensuring compliance with medical device regulations and quality systems requirements.The role works closely with R&D, Quality, Regulatory, Supply Chain, and Operations teams in a fast-paced startup environment.Key ResponsibilitiesNew Product Development & Design TransferLead manufacturing engineering activities for new product development from early design through commercializationDefine and develop manufacturing processes, work instructions, fixtures, tooling, and test methods.Drive DFM/DFA feedback to R&D during product developmentPlan and execute design transfer activities, including pilot builds and production ramp upSupport supplier selection, qualification, and technology transfer to contract manufacturersSustaining Manufacturing EngineeringProvide manufacturing engineering support for commercialized productsLead and implement process changes to improve yield, quality, cost, and throughputSupport investigations of manufacturing noncomformances, deviations, and CAPAsAddress component obsolescence, supplier changes, and process optimization initiativesProcess Validation & DocumentationPlan, execute, and document process validations (IQ/OQ/PQ)Develop and maintain manufacturing documentation, including:Manufacturing and assembly instructionsProcess flow diagrams and PFMEAsValidation protocols and reportsDMR inputs and updatesEnsure traceability between design requirements, process controls, and validation evidenceQuality, Compliance & Risk ManagementEnsure manufacturing processes comply with 21 CFR 820, ISO 13485, and applicable standardsParticipate in risk management activities per ISO 14971Support internal and external audits, inspections, and regulatory inquiriesCross-Functional CollaborationPartner with R&D, Quality, Regulatory, and Supply Chain on product and process changesSupport manufacturing readiness reviews, change review boards, and management reviewsProvide on-site or remote support to contract manufacturers as neededQualifications:Bachelor's degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering, or related field10+ years of manufacturing engineering experience, preferably in medical devices or regulated industriesStrong experience with design transfer, process development, and production scale-upHands-on experience with process validation (IQ/OQ/PQ)Experience supporting commercial and post-market productsExperience in a medical device startup or small company environmentExperience working with contract manufacturers and external suppliersFamiliarity with FDA and Iso regulatory requirements (21CFR 820, ISO 13485)Experience with lean manufacturing, yield improvement, and cost reduction

Created: 2026-05-09