The Sustaining Center Electrical Engineer position focuses on advanced electrical engineering expertise combined with a strong understanding of sustaining project management processes. This role manages product changes at all levels, executes verification and validation activities, and supports electronic assemblies throughout the product lifecycle.
The position is responsible for circuit analysis, schematic reviews, electronic board development support, manufacturing test integrity assessments (in-line and end-of-line), and design transfer activities. All activities are conducted in compliance with applicable FDA, ISO, and internal quality requirements to support manufacturing transfer, supply chain continuity, and the application ecosystem of medical products manufactured at Fresenius Medical Care Reynosa.
Responsibilities:
- Leads sustaining changes and understands their impact on the serial production process and the necessity to provide support as needed (focus on changes of production process triggered by design changes or vice versa).
- Lead and implement engineering changes (CR/CN) for electronic components and assemblies
- Perform circuit analysis and troubleshoot PCB assemblies and electronic systems
- Support design verification and validation (test protocols, execution, reports)
- Ensure manufacturing test system integrity (in-line and end-of-line testing)
- Support design transfer activities between R&D and Manufacturing
- Conduct root cause analysis for production, quality, and field issues
- Maintain documentation and configuration of electronic hardware
- Collaborate with cross-functional and global teams
- Support production and new product implementations
Qualifications:
- Bachelor’s degree of science in the field of Electrical/Electronic Engineering. Electromechanical or Mechatronics background preferred. Master’s degree is preferred or in process.
- 2–5 years of experience in sustaining, manufacturing, or product engineering
- Strong knowledge of analog and digital circuits
- Experience troubleshooting PCB assemblies and electronic systems
- Knowledge of validation, change control, and quality systems
- Experience in medical devices or regulated industries
- Knowledge of design tools (SPICE, OrCAD)
- Experience with manufacturing test systems and validation
- Familiarity with FDA, ISO, and regulatory requirements
- Basic knowledge of embedded programming (C/C++)
- Bilingual: English & Spanish
