Design Control Engineer

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