Design Control Engineer

Freelance Design Control Engineer - Medical Devices (Germany, Remote/Hybrid)
Location: Germany (Remote or Hybrid options available)
Contract Type: Freelance
Sector: Medical Devices

Role Overview
We are looking for a skilled and experienced Design Control Engineer to support our product development and regulatory compliance activities within the medical device sector. This freelance opportunity is ideal for professionals with a strong command of ISO 13485, ISO 14971, and EU MDR/FDA regulations.

Responsibilities

• Lead and maintain design control documentation across the product lifecycle
• Collaborate with cross-functional teams including R&D, Quality, and Regulatory Affairs
• Conduct and document risk management activities (e.g., FMEA, FTA)
• Support verification and validation planning and execution
• Assist in audit preparation and regulatory submissions (e.g., CE Marking, 510(k))

Requirements

• Demonstrated experience in design control within the medical device industry
• In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, and EU MDR/FDA QSR
• Experience with Class II/III devices or combination products is advantageous
• Fluent in German; English language skills are a plus
• Must be based in Germany or eligible to work as a freelancer in Germany