Manufacturing Engineering, Assembly Job at ANEUVO in Los Angeles

Company Description ANEUVO is a platform and therapy development company focused on treating disabling diseases and conditions that are not curable through traditional pharmaceutical approaches. The ANEUVO ExaStim® Stimulation System is a non-invasive neuromodulation system that has received CE Mark approval and FDA Breakthrough Device Designation for treating spinal cord injury. ExaStim® is currently cleared for use only in Europe, and its use is limited by United States law to investigational purposes. 1) Process Development (In-House) Design, develop, and validate in-house manufacturing processes, including assembly, labeling, packaging, and testing. Create process documentation such as work instructions, manufacturing travelers, and Identify and implement process improvements to enhance quality, efficiency, and yield. Support setup and qualification of new equipment, tooling, and fixtures. 2) Contract Manufacturer (CM) Support Collaborate with contract manufacturers to transfer processes, troubleshoot production issues, and ensure alignment with company quality and performance standards. Review and approve CM process documentation, validations, and change controls. Serve as the technical liaison between internal engineering and external manufacturing partners. Support pilot builds, process qualifications, and ramp-up to full production. Coordinate process transfer from development to manufacturing. 4) Continuous Improvement & Quality Drive continuous improvement through Lean and Six Sigma methodologies. implementation. Ensure compliance with applicable quality system regulations (e.g., Support audits and regulatory inspections by providing technical documentation and process Ensure processes meet safety and environmental standards. Bachelor’s degree in Electrical, Mechanical, Manufacturing, Industrial, or Biomedical Engineering (or equivalent). 7+ years of experience in manufacturing engineering, preferably within a regulated industry (medical device, pharma, or aerospace). ~ Hands-on experience with process development, validation, and supplier/CM management. Experience with statistical analysis tools (e.g., Proficient in CAD tools and solid understanding of GD&T and design documentation. ~ Excellent communication and project management skills.