Job Title: Senior Manufacturing Engineer
Location: Los Angeles, CA (On-site)
Company Overview:
Aneuvo 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 aneuvo.com.
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 Responsibilities:
- New Product Development & Design Transfer
- Lead manufacturing engineering activities for new product development from early design through commercialization
- Define and develop manufacturing processes, work instructions, fixtures, tooling, and test methods.
- Drive DFM/DFA feedback to R&D during product development
- Plan and execute design transfer activities, including pilot builds and production ramp up
- Support supplier selection, qualification, and technology transfer to contract manufacturers
- Sustaining Manufacturing Engineering
- Provide manufacturing engineering support for commercialized products
- Lead and implement process changes to improve yield, quality, cost, and throughput
- Support investigations of manufacturing noncomformances, deviations, and CAPAs
- Address component obsolescence, supplier changes, and process optimization initiatives
- Process Validation & Documentation
- Plan, execute, and document process validations (IQ/OQ/PQ)
- Develop and maintain manufacturing documentation, including:
- Manufacturing and assembly instructions
- Process flow diagrams and PFMEAs
- Validation protocols and reports
- DMR inputs and updates
- Ensure traceability between design requirements, process controls, and validation evidence
- Quality, Compliance & Risk Management
- Ensure manufacturing processes comply with 21 CFR 820, ISO 13485, and applicable standards
- Participate in risk management activities per ISO 14971
- Support internal and external audits, inspections, and regulatory inquiries
- Cross-Functional Collaboration
- Partner with R&D, Quality, Regulatory, and Supply Chain on product and process changes
- Support manufacturing readiness reviews, change review boards, and management reviews
- Provide on-site or remote support to contract manufacturers as needed
Qualifications:
- Bachelor’s degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering, or related field
- 10+ years of manufacturing engineering experience, preferably in medical devices or regulated industries
- Strong experience with design transfer, process development, and production scale-up
- Hands-on experience with process validation (IQ/OQ/PQ)
- Experience supporting commercial and post-market products
- Experience in a medical device startup or small company environment
- Experience working with contract manufacturers and external suppliers
- Familiarity with FDA and Iso regulatory requirements (21CFR 820, ISO 13485)
- Experience with lean manufacturing, yield improvement, and cost reduction
