Component Engineer

Component 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 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 Component Engineer supports the selection qualification and lifecycle management of electrical and mechanical components used in our medical devices. This role works closely with Engineering Manufacturing Quality Purchasing and Suppliers to ensure components meet quality performance reliability and regulatory requirements while supporting business continuity and product innovation.

Your Responsibilities

Support the identification evaluation and qualification of electrical and mechanical components for new and existing products

Develop and execute component evaluation acceptance qualification verification validation and reliability test plans

Identify and qualify alternate sources and second-source components to improve material availability reliability and cost effectiveness

Collaborate with Design Engineering Manufacturing Sustaining Engineering Quality Purchasing and Suppliers to support component-related projects and production needs

Investigate component failures coordinate failure analysis activities and drive corrective actions with component manufacturers

Review analyze and optimize Bills of Materials (BOMs) at the manufacturer part level

Support Risk Management activities and maintain related documentation

Draft review and implement validation protocols validation reports GMP procedures performance qualifications and Engineering Change Orders (ECOs)

Maintain validation records and support ongoing compliance with Quality System requirements

Ensure purchased components and subassemblies comply with applicable standards and regulations including RoHS REACH UL CE CSA ISO IPC-A-610 and Conflict Minerals requirements

Maintain and execute updates to the Approved Manufacturer List (AML) and support Engineering Change Orders (ECOs) and Manufacturing Change Orders (MCOs)

Review assess and track Product Change Notifications (PCNs) from component manufacturers

Lead End-of-Life (EOL) management activities by monitoring component lifecycles and implementing solutions to minimize business impacts

Participate in supplier audits and support supplier quality initiatives as required

Serve as the primary technical contact for Contract Manufacturing partners regarding component-related issues

Monitor component technology trends and support New Product Introduction (NPI) and manufacturing activities

Your Profile

Bachelors degree in Industrial Electronics Mechanical Mechatronics or related Engineering field

1 year of experience in Engineering Manufacturing Change Control Product Support or a related field; recent graduates with relevant internship or project experience are encouraged to apply

Experience in Design Sustaining or Manufacturing Engineering within Active Medical Devices (AMD) is preferred

Knowledge of hemodialysis and peritoneal dialysis equipment is preferred

Knowledge of SAP Bills of Materials (BOMs) product costing and investment analysis

Understanding of Printed Circuit Board Assembly (PCBA) cables and harnesses and metal/plastic fabrication processes

Understanding of New Product Introduction (NPI) and manufacturing environments

Experience with SAP Windchill and IHS software is a plus

Strong analytical problem-solving and project management skills

Excellent verbal and written communication skills

Ability to work independently and in cross-functional teams

Advanced computer skills including Microsoft Excel Word and MS Project

Strong organizational data analysis and presentation skills

Ability to manage multiple priorities in a fast-paced environment

Bilingual (English/Spanish)

U.S. Visa required

Availability to travel to the U.S. and other countries as required

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.