Senior Manufacturing Engineer – Medical Devices (Lean GMP)

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA, seeks a Senior Engineer for THV Manufacturing to sustain and improve the THV production line.

You will provide hands-on manufacturing engineering support, develop and optimize processes, and create work instructions for transfer to manufacturing. The role requires a BS in Mechanical or Biomedical Engineering, 4+ years in medical devices, knowledge of IQ/OQ/PQ, GMP, Lean Six Sigma, and strong data analysis.

Qualifications

• BS in Mechanical or Biomedical Engineering required.
• Minimum of 4 years' experience in Medical Device Development or Manufacturing.
• Knowledge of IQ/OQ/PQ qualification methods.
• Experience with GMP and regulatory standards.
• Lean Six Sigma experience; certification preferred.

Responsibilities

• Provide real-time production line support and issue resolution.
• Develop and optimize manufacturing processes for efficiency and quality.
• Create training materials and work instructions for transfer to manufacturing.
• Analyze data to identify improvement opportunities and root causes.
• Lead process improvement initiatives and support equipment design.
• Document and manage non-standard build requests across groups.
• Perform process characterization and validation under guidance.
• Contribute to risk assessments and regulatory compliance.

Skills

Cross-functional collaboration

Project management

Documentation

GMP/regulatory compliance

CAD—SolidWorks

Communication

Multitasking

Attention to detail

Travel up to 10%

Education

BS in Mechanical or Biomedical Engineering

Tools

SolidWorks

IQ/OQ/PQ

Job description

JenaValve Technology, Inc. in Irvine, CA, seeks a Senior Engineer for THV Manufacturing to sustain and improve the THV production line.

You will provide hands-on manufacturing engineering support, develop and optimize processes, and create work instructions for transfer to manufacturing. The role requires a BS in Mechanical or Biomedical Engineering, 4+ years in medical devices, knowledge of IQ/OQ/PQ, GMP, Lean Six Sigma, and strong data analysis.