Sustaining Center Electrical Engineer

Sustaining Center Electrical Engineer

At Fresenius Medical Care we are the global leader in kidney care committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality innovative products services and care across the entire healthcare journey.

Guided by our visionCreating a future worth living. For patients. Worldwide. Every day.we work with purpose and compassion supported by a global team of over 110000 employees.

Within our Care Enablement segment we develop and provide life-sustaining medical products digital health solutions and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation efficiency and sustainable growth.

Our values guide how we work:

• We Care for our patients each other and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right waygrowing with purpose and leading kidney care with integrity and innovation

At our Reynosa plant in Mexico we are committed to the highest standards in the production of disposable medical products for dialysis treatments. With a dedicated team of more than 3000 employees across four manufacturing sites the plant focuses on manufacturing essential components such as hemodialysis disposables peritoneal dialysis (PD) disposables hemodialysis (HD) machines and PD cycler machines.

By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing were not only driving innovationwere also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact.

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).
• Conducts circuit analysis and support troubleshooting of electronic boards and assemblies at component and system level.
• Reads and interprets electrical schematics PCB layouts and technical documentation.
• Supports development evolution and optimization of electronic boards used in active medical devices.
• Supports verification and validation activities including development and execution of test protocols and final reports.
• Ensures integrity and robustness of manufacturing test systems including in-line and end-of-line testing.
• Supports design transfer activities ensuring alignment between R&D and Manufacturing Engineering and considers design for manufacturing aspects.
• Coordinates and executes change controls (CR/CN) related to electronic components and assemblies.
• Supports product and manufacturing quality investigations related to electronic failures and field returns.
• Creates optimizes and drives structured schedules and project plans. Sets and meets deadlines with quality deliverables effectively adapting and modifying plans based on changing conditions or data.
• As cross-functional team member collaborates across all functional areas - R&D M&SC Product Management QA/QC Regulatory Design Quality Assurance Procurement Clinical Operations Service Operation and others - necessary to ensure successful project completion and delivery.
• Plans resource requirements and negotiates core team resources with R&D functional managers; assists core team members in negotiating extended team staffing of sustaining projects.
• Conducts research and development activities in compliance with GMP and FDA regulatory guidelines.
• Conducts device electrical and hardware functional testing.
• Develops prototypes by researching different technologies materials design and is responsible for developing testing and inspection criteria.
• Coordinates design verification testing and validation of the product hardware and structures the results to be presented to the management.
• Develops and executes hardware design verification protocols including final reports and validation.
• Coordinates and executes change controls and design control processes within and between facilities and corporate level.
• Determines and evaluates product design-patentability manufacture-ability and patient-safety.
• Facilitates product design researches in patent validation plastic material specification and functionality in accordance to the latest applicable standards.
• Supports the products regulatory registration 510(k) NDA HDE IDE CE marks biocompatibility etc.
• Supports work instruction (module) creation with manufacturing for product/project implementation.
• Writes CCNs to upload SOPs specifications drawings Engineering BOMs (to prepare MBOM/SAP transactions).
• Facilitates project status within the defined reporting structure. Contributes to or provides project status reports in written form and escalations to stakeholders and management
• Provides Support to the Production Department during implementations of new products and regular production.
• Functions as key player for product cost-down development and registration in International Markets and sustaining innovation and business development in support of product leader.
• Manages and implements all level complexity changes to existing and in-market products.
• Develops and/or validates engineering test methods applicable to specific product changes fixtures and/or processes.
• Supports/leads the development of electrical hardware pFMEAs and dFMEAs.
• Supports the development activities for the Risk Management Phases during the design control process such as risk review meetings.
• Generates deviation notices (DN) for project related activities lead by the Engineering group.
• Leads technical assessments for replacement parts due to End of Life/Obsolescence issues. Conducts Technical reviews with cross functional teams to assess/qualify new electrical-electronic (EE) components and changes to EE designs.
• Experienced and able to work with external labs such as UL TUV for design certification purposes.
• Experienced with FPGA and CPLD programming techniques.
• Good understanding of Design for Electromagnetic Compatibility and EMI/EMC testing.
• Complies with the Code of Business Conduct and all applicable company policies FDA QSR ISO 13485 and regulatory requirements.

Qualifications:

• Accredited Universitys bachelors degree of science in the field of Electrical/Electronic Engineering. Electromechanical or Mechatronics background preferred. Masters degree is preferred or in process.
• At least 2 years in medical device industry is preferred.
• 25 years of related experience in sustaining engineering manufacturing engineering or technical investigations preferred.
• Experience with design verification manufacturing test systems quality management systems and design transfer is preferred.
• Effective written and oral communication skills in English and Spanish.
• Strong understanding of analog and digital circuits.
• Ability to troubleshoot PCB assemblies and electronic systems.
• Knowledge of manufacturing test integrity and validation methods.
• Understanding of hardware configuration management and documentation control.
• Project management skills and familiarity with project management tools is preferred.
• Analytical structured and results-oriented mindset.
• Must be proficient in the use of Project management tools to develop schedules allocate resources and track progress.
• Basic knowledge of Hemo-dialysis machines is preferred.
• Knowledge of manufacturing processes (molding automation assembly of active medical devices as well as the design and development process (FDA compliant) for medical devices is preferred.
• Knowledge and experience of ISO CE and TUV certification is preferred.
• Knowledge and experience with electronic hardware design tools such as SPICE and electronic board layout tools such as OrCAD is required.
• Knowledge of design of experiment statistical skills and Mini-Tab is preferred.
• Knowledge of basic plastic property and project management tools.
• Basic knowledge of embedded programming (C C etc.).
• Ability to prioritize and work with multiple low to medium priority projects concurrently.
• Availability to work closely under guidance of U.S. / Germany (intercultural global collaboration).
• Stress resistant (Firebrigade when it comes e.g. to production stop due to quality issues).
• Talent to lead and manage people indirectly. Ability to manage through influencing others.
• Intercultural awareness and ability to work within an international environment within globally distributed teams.
• Excellent communication and written skills required. Ability to condense complex information to a understandable level to push decisions if needed.
• Availability for Conferences with U.S. and Germany (time difference).

Our Offer for You:

There is a lot you can discover at Fresenius Medical Care regardless of the field of expertise or level of experienceeverything is dedicated to supporting your professional journey.

Whether in front of or behind the scenes you help make better medicine available to more people worldwide
Individual opportunities for selfdetermined career planning and professional development
A corporate culture that encourages innovative thinkingfinding the best solution together not just the fastest one
A team of committed professionals with diverse skills talents and experiences
The strength of a successful global corporation combined with the collegial culture of a midsized company