Manufacturing Engineer II

About the role

The Manufacturing Engineer II will drive process improvements, solve technical challenges, and boost operational efficiency in the production of medical devices. You will work closely with cross‑functional teams to ensure new product designs are manufacturable and existing processes meet quality and cost targets.

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, work instructions, process specifications, control plans, and validation documentation.
• Collaborate with Design Engineering, Quality, Operations, and Supply Chain on new product introductions and design changes.
• Participate in selection, qualification, installation, and validation of equipment, tooling, and processes.
• Train production personnel on new processes, equipment, and technical requirements.
• 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.
• Proven ability to own KPIs, SOP compliance, and project deliverables.
• Excellent verbal and written communication in both Spanish and English (intermediate‑advanced).

Required skills

• Proficiency with CAD software (SolidWorks or AutoCAD).
• Experience with Design of Experiments (DOE) and Statistical Process Control (SPC).
• Root‑cause analysis, Lean Manufacturing, and Six Sigma methodologies.
• Data analysis tools for process monitoring.
• Ability to interpret engineering drawings, technical specifications, and engineering standards.
• Knowledge of ISO 13485 and FDA regulatory requirements.