Job Description:
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.
This function include the following relevant tasks:
- 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
Job Requirements:
- 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
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Operating Company:
Nobel Biocare
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