ANEUVO · 1 week ago
Manufacturing Engineer - Medical Devices
Los Angeles, CA
Full-time
Onsite
Senior Level
7+ years expANEUVO is a platform and therapy development company focused on treating disabling diseases and conditions that are not curable through traditional pharmaceutical approaches. The role involves designing, developing, and validating in-house manufacturing processes while collaborating with contract manufacturers and driving continuous improvement initiatives.
BiotechnologyHealth CareLife ScienceMedical DeviceRehabilitation
Responsibilities
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
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
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)
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
Qualification
Required
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
Company
ANEUVO
ANEUVO is a platform therapy development company focused on development of disruptive neuromodulation technologies.
11-50 employees
H1B Sponsorship
ANEUVO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$1.45MKey Investors
National Science Foundation
2022-04-27Series B
2021-08-19Grant· $1M
2020-01-06Grant· $0.23M
Leadership Team
Yi-Kai Lo
Chief Executive Officer
Recent News
2024-04-14
2024-04-14
Google Patent
2024-04-14
Company data provided by crunchbase