What are the responsibilities and job description for the Senior Manufacturing Engineer position at ANEUVO?
Job Title: Senior Manufacturing Engineer
Location: Los Angeles, CA
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 system requirements. The role works
closely with R&D, Quality, Regulatory, Supply Chain, and Operations teams in a fast-paced
startup environment.
ANEUVO is developing breakthrough neuromodulation devices and bioelectronic medicine to
treat diseases and injuries that are incurable with conventional pharmacological agents. We are
building a cohesive team with complementary and multidisciplinary expertise to develop and
bring our products to market.
Key Responsibilities:
• New Product Development & Design Transfer
o Lead manufacturing engineering activities for new product development from early
design through commercialization
o Define and develop manufacturing processes, work instructions, fixtures, tooling, and
test methods
o Drive DFM/DFA feedback to R&D during product development
o Plan and execute design transfer activities, including pilot builds and production ramp-
up.
o Support supplier selection, qualification, and technology transfer to contract
manufacturers
• Sustaining Manufacturing Engineering
o Provide manufacturing engineering support for commercialized products
o Lead and implement process changes to improve yield, quality, cost, and throughput
o Support investigations of manufacturing nonconformances, deviations, and CAPAs
o Address component obsolescence, supplier changes, and process optimization
initiatives
• Process Validation & Documentation
o Plan, execute, and document process validations (IQ/OQ/PQ)
o Develop and maintain manufacturing documentation, including:
▪ Manufacturing and assembly instructions
▪ Process flow diagrams and PFMEAs
▪ Validation protocols and reports
▪ DMR inputs and updates
o Ensure traceability between design requirements, process controls, and validation
evidence.
• Quality, Compliance & Risk Management
o Ensure manufacturing processes comply with 21 CFR 820, ISO 13485, and applicable
standards
o Participate in risk management activities per ISO 14971
o Support internal and external audits, inspections, and regulatory inquiries
• Cross-Functional Collaboration
o Partner with R&D, Quality, Regulatory, and Supply Chain on product and process
changes
o Support manufacturing readiness reviews, change review boards, and management
reviews
o Provide on-site or remote support to contract manufacturers as needed
Qualification:
• 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 (21 CFR 820, ISO 13485)
• Experience with lean manufacturing, yield improvement, and cost reduction