Manufacturing Engineer - Medical Devices

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 Exa Stim® Stimulation System is a non‑invasive neuromodulation system that has received CE Mark approval and FDA Breakthrough Device Designation for treating spinal cord injury. Exa Stim® is currently cleared for use only in Europe, and its use is limited by United States law to investigational purposes.

• 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 validation protocols (IQ/OQ/PQ).
  • Identify and implement process improvements to enhance quality, efficiency, and yield.
  • Support setup and qualification of new equipment, tooling, and fixtures.
  • 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.
• New Product Introduction (NPI)
  • Participate in design reviews to ensure manufacturability and scalability of new designs.
  • Support pilot builds, process qualifications, and ramp-up to full production.
  • Coordinate process transfer from development to manufacturing.
• Continuous Improvement
  • Drive continuous improvement through Lean and Six Sigma methodologies.
  • Investigate root causes of non-conformances and lead corrective/preventive action implementation.
  • Ensure compliance with applicable quality system regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
• Documentation & Compliance
  • Maintain accurate and complete process documentation.
  • Support audits and regulatory inspections by providing technical documentation and process evidence.
  • 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.

• 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.