Sustaining Center Mechanical Engineer

The Sustaining Center Mechanical Engineer role focuses on deep mechanical engineering expertise combined with a broad understanding of sustaining project management processes. This position manages product changes at all levels refurbishment programs and hardware configuration management in full compliance with FDA ISO and internal quality system requirements.

The role is responsible for engineering analysis design change implementation and applied research to support manufacturing transfer supply chain continuity and the overall application ecosystem of medical products manufactured at Fresenius Medical Care Reynosa.

Responsibilities:

• Lead engineering changes impacting products and manufacturing processes
• Troubleshoot mechanical and basic electronic issues (hands-on)
• Perform root cause analysis for production quality and field issues
• Support refurbishment rework and sustaining programs
• Manage hardware configuration (BOMs drawings specifications SAP updates)
• Develop and validate testing methods and support product verification/validation
• Coordinate change controls (CR/CN) and ensure compliance with FDA/ISO standards
• Collaborate with global teams (R&D Quality Manufacturing Regulatory)
• Support production during new implementations and ongoing operations
• Contribute to cost reduction and product improvement initiatives

Qualifications:

• BS degree or Engineering in fields of Mechanical Engineering is required. Electromechanical or Mechatronics background preferred. Masters degree is preferred or in process.
• 25 years of experience in sustaining manufacturing or product engineering
• Experience in regulated industries (medical devices preferred)
• Strong troubleshooting and hands-on technical skills (soldering is a plus)
• Knowledge of CAPA change control and quality systems
• Experience with engineering documentation and hardware configuration
• Familiarity with manufacturing processes and product development
• Experience with SAP and engineering documentation
• Knowledge of manufacturing processes and product development
• Familiarity with FDA ISO and regulatory requirements
• Bilingual: English & Spanish