Manufacturing Engineer II - Electrophysiology

About the role

The Manufacturing Engineer II will support the electrophysiology production lines at Heraeus Medevio, ensuring continuous, compliant operation of manufacturing processes. You will lead complex projects, drive improvements, and work closely with cross‑functional teams to maintain product quality and regulatory compliance.

Key responsibilities

• Lead and execute engineering projects that support current production needs and new product transfers.
• Coordinate with quality, production, and R&D to prevent interruptions and align improvements with standards.
• Apply Six Sigma DMAIC, DOE, and Lean tools for problem solving and continuous improvement.
• Maintain documentation and records post‑release, ensuring adherence to manufacturing and quality regulations.
• Validate processes and products to meet ISO 13485 and other regulatory requirements.
• Provide audit evidence and demonstrate compliance with quality systems.
• Promote cost‑effective improvements, managing CAPEX, budget control, and COGS.

Required profile

• Bachelor’s degree in Engineering or a related field.
• 3–5 years of experience in manufacturing engineering, preferably in the medical device sector.
• Experience with validation of manufacturing processes is a plus.
• Strong analytical and critical‑thinking abilities.
• Fluent in English and Spanish, both written and spoken.

Required skills

• Six Sigma DMAIC methodology.
• Lean manufacturing principles.
• Design of Experiments (DOE).
• ISO 13485 knowledge.
• CAPEX, budget control, and COGS management.
• AutoCAD and SolidWorks (preferred).