Senior R&D Engineer

The Senior R&D Engineer leads the design, development, verification, validation, and lifecycle management of medical devices, providing technical leadership and ensuring compliance with regulatory and quality requirements.

• Lead product development
• Technical decision-making
• Design Verification and Validation
• Risk management
• Regulatory compliance
• Cross-functional collaboration
• Innovation activities
• Mentoring of junior engineers.
• Evaluate field performance and reliability data (Trend Reporting)
• Financial scope is defined in the budget
• Detailed responsibilities are defined in the QMS
• Modeling Circle values and promoting the use of EBS tools.
• Preparing budget and adjusting forecasts and accruals as needed

• Bachelor's or Master's degree in Engineering or related field; typically multiple years of experience in medical device development. Completed PhD research project is a pre.
• In depth knowledge on standards and regulation including but not limited to:
• Design Controls, ISO 13485, ISO 14971, EU MDR, FDA regulations, V&V, systems engineering, CAD, risk management, etc.
• Project management competence and experience, ability to work in a team.
• Consequent and efficient, compliant and pragmatic
• Ability to work cross-functionally
• Agility to learn and to adapt individual and team performance to company standards and expectations
• Fluent in German and English, both in conversation as well as in writing
• Position requires a seasoned R&D professional with the potential for further personal development
• Relevant experience in Quality management and the regulated medical devices environment
• Experience in interacting with other departments, from cross-functional work and a basic understanding from all functions in the company

Operating company:

Nobel Biocare