Aneuvo Jobs in Usa

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.

We are currently looking for a detail-oriented and reliable Production Operator / Technician to join our manufacturing team in producing high-quality medical devices. You will be responsible for operating equipment, assembling components, inspecting products, and ensuring adherence to strict regulatory standards such as ISO 13485 and FDA cGMP.

Key Responsibilities:

• Operate and monitor production equipment according to SOPs (Standard Operating Procedures)
• Assemble medical device components manually or using automated tools
• Perform in-process inspections and testing to ensure product quality
• Maintain accurate records of production output, defects, and downtime
• Follow Good Manufacturing Practices (GMP), cleanroom protocols, and safety guidelines
• Participate in root cause analysis and continuous improvement activities
• Support equipment maintenance, calibration, and troubleshooting
• Collaborate with quality, engineering, and warehouse teams to meet production goals

Qualification:

• High School diploma or GED required; Associate degree or technical certification preferred
• 3 to 5 years of experience in a manufacturing environment, preferably medical device or pharmaceutical
• Basic knowledge of GMP, ISO 13485, and cleanroom standards
• Ability to read technical drawings, work instructions, and production schedules
• Strong attention to detail and manual dexterity
• Ability to stand for long periods and lift up to 30 lbs
• Comfortable working in controlled environments

Preferred Qualification:

• Experience with medical device assembly
• Familiarity with electronic batch records (EBR) and ERP systems
• Ability to work effectively in a team-oriented, fast-paced environment
• Good written and verbal communication skills

What we offer:

• A unique opportunity to drive a revolution in medical practices and to significantly improve the health condition of patients
• A unique environment for you to exercise your talents and be impactful
• Medical, dental and vision insurance
• Employee stock options

Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.

Company Description

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 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, and

validation 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) Support

a.     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 & Quality

a.     Drive continuous improvement through Lean and Six Sigma methodologies.

b.     Investigate root causes of non-conformances and lead corrective/preventive action

implementation.

c.     Ensure compliance with applicable quality system regulations (e.g., FDA 21 CFR Part 820, ISO

13485).

5)    Documentation & Compliance

a.     Maintain accurate and complete process documentation.

b.     Support audits and regulatory inspections by providing technical documentation and process

evidence.

c.     Ensure processes meet safety and environmental standards.

Qualifications

1)    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.