Quality Engineer - TX-61998424

EPM Scientific

Location: Germany (Hybrid)

Contract: 12 months

About the Role

We are looking for an experienced Systems Engineer to join a leading medical device manufacturer in Germany. This is a hybrid role supporting the development and compliance of Class IIb/III medical devices .

Responsibilities

• Manage system requirements and design controls in line with ISO 13485 and EU MDR .
• Support verification and validation activities for hardware/software systems.
• Conduct risk management (ISO 14971) and ensure regulatory compliance.
• Collaborate with cross-functional teams on design, quality, and manufacturing transfer.

Requirements

• Degree in Engineering or related field.
• 5+ years' experience in medical device development (Class IIb/III).
• Strong knowledge of ISO 13485 , IEC 60601 , IEC 62304 , and EU MDR.
• Fluent English; German is a plus.

Details

• Duration: 12 months
• Start: ASAP
• Working Model: Hybrid (Germany-based)