Development Engineer – Medical Devices

About

Your products treat cancer patients across 80+ countries. You own them from specification to production transfer — no hand-holding, no layers of approval. Just real engineering with direct impact. Hands-on engineering with real ownership. Not coordination, not project management.

Why this role

• Profitable and stable company with multiple MDR and FDA approved products
• Real ownership – you drive your products end to end, visible from day one
• Three engineers plus technical lead — no matrix, no middlemen, short decision paths
• Brachytherapy and radiotherapy devices used in cancer treatment daily

Your responsibilities

• Own technical documentation – DHF, DMR, test plans – within MDR
• Drive the full lifecycle from specification through verification and validation
• Lead risk management activities in line with ISO 14971
• Communicate directly with suppliers on a technical level
• Coordinate testing with external laboratories
• Support design transfer into production including process qualification

Your profile

• Hands-on MDR CE experience – documentation ownership, not just exposure
• Full lifecycle experience from specification to validation
• Class IIa or higher devices, demonstrable on your own product
• 3 to 7 years in medical device development
• Team-oriented mindset
• Fluent English
• Based in Berlin or willing to relocate within 3 months

Nice to have

• ISO 14971 and IEC 60601 working knowledge
• Notified body audit experience (TÜV SÜD, DEKRA, BSI)
• Background in radiation therapy or active implants
• Process engineering background looking to broaden into development

Framework

• Location: Berlin, on-site
• Compensation: up to 80,000 € fixed + performance bonus
• Working language: English
• Start: as soon as possible