Manufacturing Engineer II – Process Optimization

About the role

The Manufacturing Engineer II will lead the optimization of production processes for medical devices, ensuring high quality, cost efficiency, and regulatory compliance. You will work closely with cross‑functional teams to solve technical challenges and drive continuous improvement.

Key responsibilities

• Design, develop, and implement manufacturing process improvements to increase efficiency, reduce costs, and enhance product quality.
• Conduct root‑cause analyses and implement sustainable solutions for production issues, quality defects, and non‑conformances.
• Own assigned KPIs, monitor performance, identify gaps, and drive corrective actions.
• Maintain and update SOPs, ensuring they remain accurate, current, and compliant.
• Collaborate with Design Engineering, Quality, Operations, and Supply Chain to ensure manufacturability of new products and design changes.
• Develop and maintain technical documentation such as work instructions, process specifications, control plans, and validation records.
• Participate in selection, qualification, installation, and validation of equipment, tooling, and processes.
• Train production personnel on new processes, equipment, and procedures.
• Ensure compliance with ISO 13485, FDA regulations, and internal quality standards.
• Lead or support continuous‑improvement initiatives using Lean, Six Sigma, and structured problem‑solving methods.

Required profile

• Bachelor’s degree in Mechanical, Industrial, Electronic Engineering or a related field.
• 3–5 years of progressive manufacturing engineering experience, preferably in the medical‑device industry.
• Strong knowledge of manufacturing principles, assembly processes, and process optimization.
• Experience with Design of Experiments (DOE), Statistical Process Control (SPC), root‑cause analysis, Lean Manufacturing and Six Sigma.
• Proficiency in CAD software (SolidWorks or AutoCAD) and data‑analysis tools.
• Ability to interpret engineering drawings, technical specifications, and engineering standards.
• Excellent verbal and written communication in English and Spanish.

Required skills

• Design of Experiments (DOE)
• Statistical Process Control (SPC)
• Lean Manufacturing
• Six Sigma
• SolidWorks
• AutoCAD
• Data analysis tools
• Root‑cause analysis
• Process optimization
• SOP development and compliance