Manufacturing Engineer - Medical Devices

Company DescriptionANEUVO 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.Key Responsibilities:1) Process Development (In-House)a. Design, develop, and validate in-house manufacturing processes, including assembly, labeling,packaging, and testing.b. Create process documentation such as work instructions, manufacturing travelers, andvalidation protocols (IQ/OQ/PQ).c. Identify and implement process improvements to enhance quality, efficiency, and yield.d. Support setup and qualification of new equipment, tooling, and fixtures.2) Contract Manufacturer (CM) Supporta. Collaborate with contract manufacturers to transfer processes, troubleshoot production issues, and ensure alignment with company quality and performance standards.b. Review and approve CM process documentation, validations, and change controls.c. Serve as the technical liaison between internal engineering and external manufacturing partners.3) New Product Introduction (NPI)a. Participate in design reviews to ensure manufacturability and scalability of new designs.b. Support pilot builds, process qualifications, and ramp-up to full production.c. Coordinate process transfer from development to manufacturing.4) Continuous Improvement & Qualitya. Drive continuous improvement through Lean and Six Sigma methodologies.b. Investigate root causes of non-conformances and lead corrective/preventive actionimplementation.c. Ensure compliance with applicable quality system regulations (e.g., FDA 21 CFR Part 820, ISO13485).5) Documentation & Compliancea. Maintain accurate and complete process documentation.b. Support audits and regulatory inspections by providing technical documentation and processevidence.c. Ensure processes meet safety and environmental standards.Qualifications1) Education:Bachelor's degree in Electrical, Mechanical, Manufacturing, Industrial, or Biomedical Engineering (or equivalent).2) Experience: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.3) Skills:Strong problem-solving and analytical skills.Experience with statistical analysis tools (e.g., Minitab, JMP) and validation methodologies.Proficient in CAD tools and solid understanding of GD&T and design documentation.Excellent communication and project management skills.