Sr. Risk Management 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 vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 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 way—growing 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 3,000 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, we’re not only driving innovation—we’re also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact.
As a Sr. Risk Management Engineer ensures product safety for Medical Devices, by applying the risk management process throughout the product life cycle.
Will ensure risks are identified and addressed in accordance with the Risk Management Plan, Planning and execution of risk management process, the preparation and maintenance of the risk analysis for assigned medical devices and medicinal products (and if applicable for non-medical active or digital devices) in compliance with relevant standards and guidelines.
Your Responsibilities
- Responsible for planning and execution of system risk management processes, the preparation and maintenance of the risk analysis for assigned medical and medicinal devices (and if applicable for non-medical active or digital devices) in compliance with relevant standards and guidelines
- Responsible for the specification of risk reduction measures in (requirement management) cooperation of the Value Stream
- Ensure that all activities regarding risk management are executed according to risk management planning.
Your Profile
- Engineering degree or equivalent experience.
- Minimum 2 - 4 years of experience in similar areas of Quality Engineering for manufacturing processes, (medical devices preferably).
- Experience of 1-3 years in Research and development, Regulatory Affairs or risk management (medical devices preferably).
- Experience with Risk Management Expertise.
- Bilingual English / Spanish (excellent English communication skills required)
- knowledge of medical device risk management and related regulations
- knowledge of medical device regulations (US Medical Devices regulation, EU MDR 2017/745, MDSAP etc.)
- knowledge of applicable standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR etc.)
- Knowledge of FMEA methodology, statistical methods, statistical methods, scientific writing.
- Knowledge of TrackWise, workflow, systems like QTRAK, PDM systems like PTC, Windchill, FMEA tools.
- Bilingual English / Spanish (excellent English communication skills required)
- 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 experience—everything 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 self‑determined career planning and professional development
• A corporate culture that encourages innovative thinking—finding 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 mid‑sized company.
Skills Required
- Engineering degree or equivalent experience
- 2-4 years experience in Quality Engineering for manufacturing processes (medical devices preferred)
- 1-3 years experience in Research & Development, Regulatory Affairs, or Risk Management (medical devices preferred)
- Demonstrated risk management expertise for medical devices
- Bilingual English/Spanish with excellent English communication skills
- Knowledge of medical device risk management and related regulations
- Knowledge of US Medical Device regulation, EU MDR 2017/745, MDSAP
- Knowledge of applicable standards (ISO 13485, ISO 14971, ICH Q10, EU GMP, FDA 21 CFR)
- Knowledge of FMEA methodology, statistical methods, and scientific writing
- Experience with TrackWise, workflow systems like QTRAK, PDM systems like PTC or Windchill, and FMEA tools
- U.S. visa required
- Availability to travel to the U.S. and other countries as required
Fresenius Medical Care Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Fresenius Medical Care and has not been reviewed or approved by Fresenius Medical Care.
-
Leave & Time Off Breadth — PTO is described as ample for 3x12-hour shifts and is complemented by paid caregiver leave, holidays, and sick time. This range of time-off options provides meaningful flexibility for many roles.
-
Healthcare Strength — Medical coverage includes 100% preventive care, office-visit copays, prescription coverage, and disability insurance, while dental covers preventive, basic, and major restorative services up to an annual limit. Vision benefits are also available.
-
Wellbeing & Lifestyle Benefits — Wellness programs feature the Rally app with fitness rewards, virtual therapy, and an Employee Assistance Program with free counseling. Additional offerings like digital physical therapy and expert medical opinions broaden holistic support.
Fresenius Medical Care Insights
What We Do
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day. Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life. Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.
