Senior Manufacturing Engineer, Medical Devices (Valve)

Jenavalve Technology; Irvine (CA); On-site; USD 85,320 - 104,280; Full time

Job summary

JenaValve in Irvine, CA is seeking a Senior Engineer for THV Manufacturing to sustain and optimize valve production lines. You will support manufacturing engineering tasks, develop processes, and create work instructions for transfer to manufacturing.

The role emphasizes GMP compliance, cross-functional collaboration with R&D and Quality, and driving continuous improvement on time and within budget. Experience in medical devices is required.

Qualifications

• Bachelor of Science in Mechanical or Biomedical Engineering.
• Minimum 4 years’ experience in Medical Device Development or Manufacturing.
• Knowledge of IQ/OQ/PQ in medical devices or regulated industries.
• Knowledge of SPC and sampling plans; ability to articulate results clearly.
• Six Sigma/Lean experience; Lean Six Sigma certification preferred.
• Work Instruction creation and implementation experience.

Responsibilities

• Provide real-time production line support with GEMBA walks, troubleshooting, daily meetings, and material review boards.
• Develop and optimize manufacturing processes to improve efficiency and quality using lean principles.
• Create training and documentation materials to transfer new products to manufacturing.
• Analyze data to identify opportunities; conduct CAPA investigations and determine root causes.
• Lead short- and long-term manufacturing process improvement projects.
• Support equipment, tooling, and fixture design for development and production.
• Document and manage non-standard build requests from R&D and Quality with end-to-end support.
• Perform process characterization and validation under guidance from senior staff.
• Address issues constructively and make risk-based decisions for quality and availability.
• Ensure compliance with GMP and regulatory standards across manufacturing.

Skills

Cross-functional collaboration

Project management

Attention to detail

Documentation

GMP compliance

SolidWorks

Interpersonal skills

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

JenaValve in Irvine, CA is seeking a Senior Engineer for THV Manufacturing to sustain and optimize valve production lines. You will support manufacturing engineering tasks, develop processes, and create work instructions for transfer to manufacturing.

The role emphasizes GMP compliance, cross-functional collaboration with R&D and Quality, and driving continuous improvement on time and within budget. Experience in medical devices is required.