R&D Lead Engineer

R&D Lead Engineer – MedTech (m/f/d)📍 Berlin | On-site presence (predominantly) 💰 €85,000–105,000 fixed (with development potential) 🏥 International MedTech environment | High-impact oncology & radiotherapy solutionsWhy this role? 🚀You’ll play a pivotal role in shaping innovative applicator systems used in minimally invasive cancer therapy — combining engineering depth, MDR expertise, and cross-functional project leadership. Instead of just managing documentation, you’ll drive the link between R&D, Quality, Regulatory, and Operations to bring compliant, safe, and cutting-edge MedTech products to life.Your mission:Lead cross-functional R&D projects from concept to submission (Design Control, Verification, Validation)Own and maintain MDR-compliant technical documentation (DHF/DMR, Annex II/III)Translate engineering data into regulatory evidence – ensuring traceability and complianceCoordinate design reviews, supplier interfaces, and testing activities with QA/RA/ProductionSupport Notified Body submissions and drive closure of RfIs and change requestsFoster a hands-on, solution-oriented culture within the development teamWhat you bring:Degree in Mechanical, Biomedical or Medical Engineering (Master’s preferred)Proven experience in MDR or FDA-regulated MedTech environments (Class IIb/III)Solid background in R&D, mechanical design, or product developmentStrong understanding of Design Control, Risk Management (ISO 14971), and ValidationExperience in leading projects or small teams across engineering and regulatory functionsFluent in English; German is a plusWhat awaits you:🤝 Collaborative, international R&D environment with real decision-making power 📄 Full ownership of MDR submissions – visible impact on global product launches 🧭 Close cooperation with QA/RA and management – high strategic exposure 📈 Development opportunities within a growing MedTech group 🌍 Products that make a tangible difference in oncology treatment worldwide