Design Assurance Engineer (Medical Devices)

Location: Berlin, Germany; hybrid work

Company

Develops precision components and subsystems for healthcare and advanced manufacturing, including minimally invasive surgery, robotics, and 3D metal printing.

What you will do

• Create and support overall quality, document, and verification and validation plans.
• Review design verification and validation specifications, test specifications, reports, and design-control documentation.
• Contribute to product and design FMEA activities and the ISO 14971 risk-management process.
• Evaluate risk-reduction measures and prepare evidence of their implementation and effectiveness.
• Develop test specifications and requirements for series testing in cooperation with Quality Assurance and Production.
• Support process improvements and failure analysis for field returns and product development.

Requirements

• Completed technical or scientific studies.
• At least 2 years of professional experience.
• Experience with product quality in a highly regulated industry such as medical devices, automotive, or aviation.
• Knowledge of quality methods and techniques, design control, risk management, FMEA, and relevant standards including ISO 14971, MDR 2017, CFR 820, GLP, and GDP.
• Fluent English and legal eligibility to work in Germany are required.
• Structured, systematic, reliable, quality-conscious, and collaborative working style with good communication skills.

Culture & Benefits

• Hybrid work environment in Berlin.
• Collaboration across a global organization with offices in the Americas, Europe, and Asia-Pacific.
• Health and financial services package.
• Willingness to travel to business locations and contacts for approximately 10% of working time.