Position:
Freelance Design Engineer - Medical Devices
Location:
Remote (Germany-based)
Contract Length:
6 months
Language Requirement:
Fluent German (mandatory), English (preferred)
Start Date:
ASAP
We are seeking an experienced
Design Engineer
to support a medical device R&D team focused on developing complex electromechanical systems used in life-sustaining therapies. This freelance role offers remote flexibility but requires candidates to be based in Germany and fluent in German due to regulatory and team collaboration needs.
Key Responsibilities:
* Lead design control activities in accordance with ISO 13485, IEC 62304, and FDA 21 CFR Part 820
* Manage product lifecycle and configuration using
Windchill PTC
* Drive requirements engineering, traceability, and risk management using
Polarion ALM
* Maintain and update Design History Files (DHF), technical documentation, and change control records
* Collaborate with cross-functional teams including software, mechanical, and quality engineering
* Support verification and validation (V&V) planning and execution
* Contribute to CE marking and FDA submission documentation
Required Skills & Experience:
* Proven experience in medical device design within a regulated environment
* Strong proficiency in Windchill PTC and Polarion ALM
* Solid understanding of design control, configuration management, and documentation workflows
* Familiarity with risk analysis tools (e.g., FMEA), traceability matrices, and regulatory standards
* Experience working with electromechanical systems, fluid handling, or sensor-integrated platforms
* Ability to work independently and communicate effectively in German (written and spoken)
Preferred:
* Background in renal care or similar therapeutic areas
* Exposure to embedded software or mechatronic systems
* Experience with CE/FDA regulatory pathways