R&D Lead Engineer in Berlin

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Job Description

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 )
• 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

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.