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 solutions
Why 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 compliance
* Coordinate design reviews, supplier interfaces, and testing activities with QA/RA/Production
* Support Notified Body submissions and drive closure of RfIs and change requests
* Foster a hands-on, solution-oriented culture within the development team
What 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 development
* Strong understanding of Design Control, Risk Management (ISO 14971), and Validation
* Experience in leading projects or small teams across engineering and regulatory functions
* Fluent in English; German is a plus
What 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