Senior Engineering Consultant – Manufacturing – Medical Devices

About the role

The Senior Engineering Consultant will support the Quality department by providing sustaining quality engineering support for existing medical device manufacturing operations. The role ensures product conformity and adherence to the company’s Quality Management System.

Key responsibilities

• Assess tooling, equipment, materials, and molding processes; optimize parameters and troubleshoot defects.
• Develop, execute, and document validations (IQ, OQ, PQ) and analyze results using statistical methods.
• Update molding validation strategies, establish process controls, setup instructions, and inspection requirements.
• Train manufacturing personnel and support transfer to routine production, delivering prioritized improvement plans and updated work instructions.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 8 years of experience in manufacturing engineering, preferably with injection molding.
• Fluent in English (reading, writing, speaking) and native Spanish speaker.

Required skills

• Advanced MS Office (Word, Excel, PowerPoint, Project, Visio).
• Proficiency with Minitab for statistical analysis.
• Experience using SolidWorks, Pro/E or Inventor for 3D modeling.
• Knowledge of electronic document management systems.