other
Added 2 weeks ago(Senior) Expert Biocompatibility (m/w/d)
at NextStage
Bad Homburg, He, United StatesOn-site
Requirements
- requirements as well as material selection Observe upcoming regulation changes and ensure timely implementation considering state-of-the art methodology Your profile Successfully completed master’s degree in scientific or engineering or a similar technical field required, such as medical technology Related working
- experience: 2–8 years, depending on level (Expert / Senior Expert) Highly Experienced in writing biocompatibility evaluations Deep Knowledge with biocompatibility-testing and evaluations of medical devices according to ISO 10993 Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO 13485, and ISO 14971 Strong Knowledge with medical device risk management process and related regulations
- Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding Ability to communicate technical information to non-technical audiences Familiar with agile methodology Proven track record in project and/or test management Proficient with ALM and PDM systems Familiar with durables and disposables of medical devices Fluent in German and English, both written and spoken Willingness to travel on an
- experience you have - all dedicated to your professional journey.
Benefits
- 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.
- 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 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 Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle.