Senior Manufacturing Engineer, Medical Devices – Lean & GMP

Jenavalve Technology Inc; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Jenavalve Technology Inc. is seeking a Senior Engineer, THV Manufacturing to oversee manufacturing engineering tasks for sustaining our valve production line.

You will provide real-time line support, generate data-driven improvements, and develop training and work instructions for seamless product transfers. The role requires a BS in Mechanical or Biomedical Engineering, 4+ years in medical device manufacturing, knowledge of IQ/OQ/PQ, and Lean/Six Sigma experience.

Qualifications

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

Responsibilities

• Provide real-time production line support, including GEMBA walks and equipment troubleshooting.
• Develop and optimize manufacturing processes using lean principles to improve efficiency and quality.
• Create training and documentation materials (e.g., work instructions) for production transfer to manufacturing.
• Generate, analyze and summarize data to identify improvement opportunities and set process limits.
• Conduct CAPA investigations to determine root causes of defects or trends.
• Lead short- and long-term manufacturing process improvement projects.
• Support equipment, tooling, and fixture design for development and production activities.
• Document and manage non-standard manufacturing build requests from cross-functional groups.
• Perform process characterization and validation under guidance of a project leader.
• Make risk-based decisions to ensure product quality, regulatory compliance and availability.

Skills

Cross-functional collaboration

Project management

Documentation

Communication

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

Jenavalve Technology Inc. is seeking a Senior Engineer, THV Manufacturing to oversee manufacturing engineering tasks for sustaining our valve production line.

You will provide real-time line support, generate data-driven improvements, and develop training and work instructions for seamless product transfers. The role requires a BS in Mechanical or Biomedical Engineering, 4+ years in medical device manufacturing, knowledge of IQ/OQ/PQ, and Lean/Six Sigma experience.